Archive for the ‘Hypogonadism’ Category

Testosterone is more than just a sex hormone. Its role goes beyond giving pubescent boys growth spurts, and its effects on the male body are lifelong. But talk of a male menopause, marked by reduced testosterone from middle age, is often met with controversy.

Here are a few things you might not know about men and testosterone:

Testosterone plays a part in maintaining muscle mass, physical energy and mental alertness, as well as libido and sexual stimulation . Since these characteristics are associated with youth, it's no surprise that men produce gradually less testosterone as they age. The rate of decline varies, but levels typically drop by around 20 to 50 per cent between early adulthood when they are at their peak and when a man reaches his 80s .

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The medical term for low testosterone in men is 'male hypogonadism'. It can be caused by problems with the testicles, for example resulting from infection, chemotherapy, certain autoimmune conditions and some tumours.

It can also signal a condition affecting the pituitary gland, which sits at the bottom of the brain stem. If the function of the pituitary gland becomes impaired through a head injury, tumour or using anabolic steroids, for example it has a knock-on effect on certain hormones, which in turn means the testicles don't make as much testosterone.

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Professor Mike Kirby, a GP and visiting professor to the Prostate Centre, says that as they get older, men develop more long-term conditions "such as diabetes, metabolic syndrome and cardiovascular disease and all those things impact on testosterone levels".

Being overweight or obese, also more common in older than in younger men, is also linked with hypogonadism.

So, although it's normal for testosterone levels to fall a certain amount as men get older, the ageing process itself doesn't ordinarily cause testosterone to dip beneath the lower end of normal range. Other health problems are responsible for almost all cases of reduced testosterone in older men, and that, says consultant endocrinologist Dr Richard Quinton, negates the concept of a male menopause. He says:

"For a tiny minority, there is a slightly similar phenomenon to the female menopause, but it's mild and partial rather than complete and absolute."

When a man's testosterone levels are low, he'll often get quite vague symptoms. As well as a change in the sex department loss of libido and erectile dysfunction he might experience difficulty concentrating, insomnia, mood disturbances, weight gain and loss of muscle bulk.

These signs are all-too-easy to ignore, but Dr John Chisholm CBE, a GP and chair of the Men's Health Forum, urges men to get them checked:

"Erectile dysfunction in particular should be looked into because it can be a symptom of serious underlying disease."

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Low testosterone levels can be confirmed by a blood test, and the standard treatment is testosterone replacement by way of a tablet, patch, gel, implant or injection . Evidence suggests that with regular monitoring, testosterone treatment is safe, effective and relatively free of side effects when it's prescribed appropriately .

The problem is that experts disagree about who should be prescribed testosterone. Professor Kirby argues that men with the lowest levels of testosterone level will "almost certainly benefit from treatment regardless of the cause" and that in men whose levels are at the lower end of normal, "it may well be worth addressing the cause first, but some would still benefit from testosterone treatment".

But others, including Dr Quinton, dispute this. He supports treatment only in men who are "genuinely hypogonadal" in other words, those who have consistently low testosterone but aren't obese and have no underlying illness.

"Giving testosterone to men who are either normal, or just have hypogonadism due to chronic ill health including obesity cannot be justified on the basis of available safety and efficacy data."

As well as restoring testosterone levels, testosterone treatment slows the production of certain hormones, switching off sperm production in the testicles. Alternative hormone treatments can work for younger men and those who want to maintain their fertility.

The clear message is that if you're worried about anything, talk to your doctor. The chances are symptoms are nothing to worry about and any problems can be easily rectified

"We'd also recommend they seek help if they're experiencing mental health disturbance. It's better to talk than to avoid issues and conceal symptoms."

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8 things you need to know about testosterone and 'the male menopause' - Netdoctor

A high prevalence of hypogonadism in men with Type-2 diabetes mellitus (T2DM) has been reported worldwide.

To evaluate the prevalence of hypogonadism in Indian males with T2DM and assess the primary and secondary hypogonadism along with androgen deficiency.

In this cross-sectional study, 900 men with T2DM were evaluated using androgen deficiency in aging male questionnaire. They were screened for demographic characteristics, gonadal hormone levels, lipid profile, and glycosylated hemoglobin.

The prevalence of hypogonadism in T2DM patients was found to be 20.7% (186 out of 900). Hypogonadism was of testicular origin (primary) in 48/186 (25.8%) patients, of pituitary or hypothalamic origin (secondary) in 14/186 (7.53%), and remaining 124/186 (66.67%) patients were found to have low testosterone with the inappropriate normal level of luteinizing hormone and Follicle-stimulating hormone. 451/900 (50.1%) patients were only symptomatic but had normal testosterone levels. Further 263 patients out 900 were asymptomatic, of which 51/900 (5.7%) patients had low levels of testosterone and 212/900 (23.5%) patients had normal testosterone level without symptoms. There were no deaths or other serious adverse events except mild pyrexia which was not related to the study.

Hypogonadism diagnosis, at times, might not be validated with the help of androgen deficiency questionnaire or symptoms only. Given the large number of patients of T2DM in India, the incidence of hypogonadism is more in diabetic patients as compared to the general population. Hence, implementation of screening programs in diabetic patients is necessary to understand and detect individuals with low serum total testosterone at any early stage and to supplement testosterone accordingly.

Indian journal of endocrinology and metabolism. 0000 Jan [Epub]

Pankaj Kumar Agarwal, Parminder Singh, Subhankar Chowdhury, S K Sharma, Anirban Majumdar, Parag Shah, Rakesh Sahay, S Vageesh Ayyar, Hemant Phatale, Chandar M Batra, Raeesuddin Syed, Pradeep Shetty

Hormone Care and Research Center, Near St. Mary's School, Ghaziabad, Uttar Pradesh, India., Department of Endocrinology, Dayanand Medical College and Hospital, Civil Lines, Ludhiana, Punjab, India., Department of Endocrinology, IPGME&R and SSKM Hospital, Ronald Ross Building, 4th Floor, 244, A J C Bose Road, Kolkata, West Bengal, India., Thyroid and Endocrine Centre, Near 4 No. ESI Hospital, Jaipur, Rajasthan, India., Thyroid and Hormone Clinic, Dhakuria, Kolkata, West Bengal, India., Gujarat Endocrine Centre, 2nd Floor, Silver Brook B, Opposite Doctor House, Near Parimal Crossing, Ahmedabad, Gujarat, India., Department of Endocrinology, Osmania General Hospital, 2nd Floor, Golden Jubilee Block, Afzalgunj, Afzalgunj, Hyderabad, Telangana, India., Department of Endocrinology, St. John's Medical College and Hospital, Bengaluru, Karnataka, India., Samrat Endocrine Institute of Diabetes, Obesity and Thyroid, Aurangabad, Maharashtra, India., Department of Endocrinology, Sarita Vihar, Delhi Mathura Road, New Delhi, India., Global Medical Affairs, MSD Pharmaceuticals Private Limited, 10th Floor, Platina Building, C-59, G-Block, Bandra Kurla Complex, Mumbai, Maharashtra, India.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28217500

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A study to evaluate the prevalence of hypogonadism in Indian males with Type-2 diabetes mellitus. - UroToday

A new study suggests that treatment with testosterone is linked with a significantly higher increase in coronary artery noncalcified plaque volume in older men with symptomatic hypogonadism. The placebo-controlled trial, conducted at nine academic medical centers in the United States, included 138 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL and symptoms suggestive of hypogonadism in the primary analysis. Of those men, 73 received testosterone treatment and 65 received placebo; and 70 overall had a coronary artery calcification score indicative of severe atherosclerosis. For the primary outcome, testosterone treatment was associated with a significantly greater increase in noncalcified plaque volume from baseline to 1 year, compared with placebo. Additionally, treatment was associated with increased total plaque volume, though not with changes in coronary artery calcium score. No major adverse cardiovascular events occurred in either of the groups. To better understand the clinical implications of the findings, the researchers note that larger studies are needed.

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Testosterone treatment and coronary artery plaque volume in older men with low testosterone - Pharmacy Today, American Pharmacists Association,...

The only male medical condition that testosterone supplements have been shown to clearly help is hypogonadism abnormally low levels of the hormone that result from a disorder of the hypothalamus, pituitary gland or testes.

But thats a relatively small market for such drugs. Hypogonadism affects only 0.1 percent of men in their 40s and just 5.1 percent of men in their 70s. So, about two decades ago, pharmaceutical companies hit upon a grand idea: They would get doctors to expand the definition of low testosterone to include any middle-aged or older man with somewhat lower testosterone levels (a drop that occurs naturally with age) as well as common age-related complaints, such as fatigue, sleep problems, weight gain, and decreased libido or physical abilities.

This medicalization of male aging, which began about a decade ago, worked. Sales of testosterone supplements for Low T skyrocketed, increasing tenfold in the United States between 2000 and 2011.

Researchers have been playing catch-up ever since, trying to figure out if testosterone supplements whether gels, patches, pills or other products really live up to all the marketing hype. In 2003, the National Academy of Medicine (then the National Institute of Medicine) called for more rigorous research to look at both the positive and negative health effects of testosterone replacement therapy in older men.

So far, concerns about the drugs have tended to heavily outweigh any claims of benefits. Indeed, in 2015, the U.S. Food and Drug Administration required the products labels to carry warnings that their use is associated with an increased risk of heart disease and stroke.

A series of new studies is unlikely to ease those concerns. The studies examined the effect of testosterone supplements on the bone health, anemia status, memory skills and cardiovascular health of older men.

Four of the studies used data from the Testosterone Trials (TTrials), which involved 790 men aged 65 and older. Half of the men were randomly assigned to take a daily dose of testosterone in the form of a gel for a year, while the others took a placebo for the same period of time. (The gel raised the mens testosterone to levels that tend to occur in healthy, younger men.)

The results were published Tuesday in the Journal of the American Medical Association (JAMA) and JAMA Internal Medicine:

Those three studies could be viewed as neutral or even mildly promising for testosterone supplements. But the same cant be said of the fourth study the one on cardiovascular health.

Its findings suggest that testosterone supplementation may raise the risk of heart disease. The men in the study who were using the testosterone gel experienced a significantly greater buildup of plaque in their arteries compared to the men who were taking the placebo. Arterial plaque is considered an early sign of heart disease.

The study was small, however, and followed the men for only a year. A larger, longer study would be needed to confirm the findings.

A fifth study, which was also published Tuesday in JAMA Internal Medicine but which was not part of the TTrials, also looked at the association between testosterone supplementation and cardiovascular outcomes, this time in more than 8,000 men aged 40 or older with low T levels of the hormone. It found that the supplementation was associated with a lower risk of stroke, angina and other heart-related outcomes.

But that study was an observational one, which means its findings do not prove that the testosterone treatments were related to the better heart outcomes. Many associations that emerge from observational studies vanish once they are tested in clinical trials.

Overall, the findings from these studies do not materially change the unfavorable balance of safety and efficacy to initiate testosterone treatment for age-related declines in the hormone, writes David Handelsman, a reproductive endocrinologist at the University of Sydney, in an editorial that accompanies the study. Rather, low testosterone levels due to obesity and other aging comorbidities are better addressed by lifestyle measures directed at those comorbidities.

Handelsman then takes the medical profession to task, noting that testosterone overprescribing has been propelled not only by direct-to-consumer advertising, but also with the complicity of some professional organizations and physicians that have supported redefinition of the term hypogonadism through permissive guidelines appearing to minimize the fundamental distinction between pathological hypogonadism and age-related, low circulating testosterone.

Those guidelines need to be revised, he stressed, to remove their tacit, uncritical endorsement of testosterone supplements as a panacea for male aging.

Hopes for hormonal rejuvenation appear periodically throughout history, he writes, but with the results of the studies published on Tuesday, the hopes for testosterone-led rejuvenation for older men are dimmed and disappointed if not yet finally dashed.

FMI: Youll find all the studies mentioned and the editorial in the Feb. 21, 2017, issues of JAMAand JAMA Internal Medicine.

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New studies fail to change 'unfavorable balance' of risks/benefits of testosterone supplements - MinnPost

The testosterone gel used in a series of trials assessing health effects.

In decades of research, scientists have found only one medical condition thats clearly and effectively treated with testosterone supplements: pathological hypogonadismthats low testosterone levels due to disease of the hypothalamus, pituitary gland, or testes.

But that hasnt stopped drug makers and the supplement industry from convincing men that jacking their testosterone will stave off the effects of aging. Getting old naturally lowers testosterone in the body. In efforts to combat Low T, testosterone sales sprung 10-fold in the US between 2000 and 2011.

In light of that trend, researchers are trying to get a handle on the health benefits of that beefed-up hormone consumption. So far, it looks wimpy.

In a series of placebo-controlled, randomized trials, researchers tracked the effect of testosterone on the cognition, bone health, anemia, and cardiovascular health of 788 men for a year. All the men were aged 65 or older and had low testosterone levels that couldnt be explained by anything other than age.

The results, reported Tuesday in JAMA and JAMA Internal Medicine, offer mixed results.

Among the 493 in the trial who also had age-related memory declines, testosterone didnt have any effect on memory or cognitive abilities. In the study, 247 got testosterone and 246 got a placebo.

But for cardiovascular health, there was an effecta bad one. Over the year,plaque buildup in the coronary arterywhich is a risk factor for heart diseaseincreased in 73 men on testosterone compared with 65 on placebo. However, other studies have found mixed results on this. Longer, bigger trials will be needed to sort out the risks.

In the anemia study, testosterone did seem to improve iron levels in men with mild anemia. The bone health study also showed that testosterone could improve bone density.

However, its unclear if those benefits outweigh the possible cardiovascular risks. And other drugs may be more effective at treating anemia and improving bone mass than testosterone.

In anaccompanying editorial, Dr. David Handelsman of the University of Sydney and Concord Hospital in Australia concluded that the overall findings do not materially change the unfavorable balance of safety and efficacy to initiate testosterone treatment for age-related hypogonadism. Thus, he added, the hopes for testosterone-led rejuvenation for older men are dimmed and disappointed if not yet finally dashed. But health experts and medical societies should revise guidelines and recommendation to best inform patients, he argued.

Testosterone misuse will not simply disappear for lack of logic or evidence as none was needed to get it startedrejuvenation fantasies thrive on hope without needing factsand educational efforts are essential.

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Studies show testosterone offers little benefits to aging men - Ars Technica

Home Men's Health Testosterone therapy may help prevent heart disease

Recent research published in the Journal of Cardiovascular Pharmacology and Therapeutics has revealed that long-term testosterone therapy (TTh) for males who have hypogonadism (or testosterone deficiency) may also help prevent cardiovascular (CV) disease. Testosterone (T) is the main male sex hormone and is responsible for the development of male reproductive tissuesit also encourages muscle, bone, and body hair growth. Males with a testosterone deficiency are at risk for developing osteoporosis, as insufficient levels contribute to weakness and bone loss.

Researchers followed two groups of men for eight years for an observational study to determine whether testosterone therapy had an effect on the risk of cardiovascular disease. The first group had been treated with testosterone therapy for their hypogonadism, while the second group had not. After the eight years, only two men from the first group had died, and neither instance was related to cardiovascular disease.

In contrast, there were 21 deaths in the second group, 19 of which were caused by cardiovascular-related events. This group also saw 26 non-fatal myocardial infarctions or heart attacks, and 30 non-fatal strokes, while the first group experienced none. Based on these results, the team concluded that long-term testosterone therapy for men with hypogonadism may be an effective method to help improve cardiometabolic function and reduce the risk of cardiovascular disease and related events.

These results show that there may be a protective benefit gained when treating hypogonadal males with long-term testosterone therapy, and with further research, it may be utilized to help prevent cardiovascular disease and events, as well as to treat testosterone deficiency.

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Heart disease risk in men linked to high testosterone and low estrogen

Testosterone may be linked to hardening of blood vessels associated with heart disease: Study

https://www.eurekalert.org/pub_releases/2017-02/bumc-ttp021317.php

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Testosterone therapy may help prevent heart disease - Bel Marra Health

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Endocrinology Drugs MarketResearch Report covers the present scenario and the growth prospects of the Endocrinology Drugs Industry for 2016-2020. Endocrinology Drugs Market, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years and discussion of the key vendors effective in this market. To calculate the market size, the report considers the revenue generated from the sales of Endocrinology Drugs globally.

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The Endocrinology Drugs Market report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors. The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. Following Companies Are Key Players of the Endocrinology Drugs Market:

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As vendors are facing the problem of a decline in venture capital investment, they are increasingly following the strategy of outsourcing. Different parts of research such as product characterization testing and toxicology testing are outsourced to third-party research organizations. Similarly, some vendors outsource the pharmaceutical product manufacturing or the entire manufacturing process to contract manufacturing organizations. This reduces the operational costs, as most companies do not have to maintain expensive R&D laboratories and scientists. Pharmaceutical companies rely on the contract manufacturing organizations based in India, China, Russia, and Eastern Europe to manufacture and process their products.

Ask Sample PDF of Endocrinology Drugs Market Report @http://www.marketreportsworld.com/enquiry/request-sample/10278756 According to the Endocrinology Drugs Market report, the increase or decrease in the release of endocrine hormones leads to disorders such as diabetes, hypogonadism, hypothyroidism, and hyperthyroidism. The prevalence of diabetes is rising because of obesity, unhealthy diet, and lack of physical activity among individuals. The prevalence of hypogonadism also increases in men with diabetes, human immunodeficiency virus (HIV), chronic obstructive pulmonary disease, heart or renal disease, or in individuals who are on opiate or glucocorticoid therapy. Thus, the increase in the prevalence of these diseases will lead to the increase in the intake of medications, propelling the market growth. Report also presents Geographical Segmentation analysis of Endocrinology Drugs Market of Americas, APAC, EMEA region.

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Despite the continued controversy surrounding the use of testosterone in men who have testosterone deficiency (hypogonadism), a new study has found that long-term use of testosterone therapy not only improves vigor and vitality, but may reduce the risk of death due to cardiovascular (CV) disease.

These findings appear online in the Journal of Cardiovascular Pharmacology and Therapeutics.

Testosterone (T) is the primary male sex hormone. In men, T plays a key role in the development of male reproductive tissues as well as promoting secondary sexual characteristics such as increased muscle and bone mass and growth of body hair. In addition, T is essential for overall health and well-being and for the prevention of osteoporosis. Insufficient levels of circulating T in men, contributes to frailty and bone loss.

In the absence of large, prospective, placebo-controlled clinical trials of longer duration, substantial evidence regarding the safety and risk of testosterone therapy (TTh) with regard to cardiovascular outcomes can only be gleaned from observational studies. To date, there are limited studies comparing the effects of long-term TTh in hypogonadal men who were treated or remained untreated with T.

Researchers at Boston University Schools of Medicine (BUSM) and Public Health (BUSPH), along with researchers in Germany, established a registry to assess long-term effectiveness and safety of T in men. For this study, they sought to compare its effects on a host of parameters (obesity, cholesterol levels, diabetes, liver function) considered to contribute to cardiovascular disease.

The researchers followed a group of men for eight years who had been on TTh and compared them with another group of men who remained untreated for the same time period. They found there were only two deaths in the TTh group and neither was related to CV events. In the non-treated control group, there were 21 deaths, 19 of which were related to CV events. Furthermore, there were 26 non-fatal myocardial infarctions and 30 non-fatal strokes in the control group but none in the T-treated group.

According to the researchers, long-term TTh in men with hypogonadism appears to be an effective approach to achieve sustained improvements in cardiometabolic function and reduces the risk of CV events. "The low CV events observed in the T-group compared to the untreated (control) group strongly suggest that TTh is protective. We believe that the protective effect of T on the CV system provides clinicians with the opportunity to utilize this approach for secondary prevention for hypogonadal men with a history of CV events," explained corresponding author Abdulmaged M. Traish, PhD, professor of biochemistry and urology at BUSM.

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Materials provided by Boston University Medical Center. Note: Content may be edited for style and length.

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Testosterone therapy provides protection against cardiovascular disease in men with low testosterone - Science Daily

Hypogonadism in Reproductive Years Renal and Urology News Hypogonadism in Reproductive Years. An obese 43-year-old male presents for evaluation of primary infertility and loss of libido. His wife is 37 and has regular periods but has moderate premature ovarian failure. Aside from the obesity, the physical ...

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Hypogonadism in Reproductive Years - Renal and Urology News

US Recall News (press release)

Low Testosterone Products Litigation US Recall News (press release) Between 3 and 7 percent of the male population in the US develop hypogonadism. One of the symptoms of this condition is a testosterone deficiency. Other symptoms include fatigue and low libido. Testosterone products were the go-to medication for men ...

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Low Testosterone Products Litigation - US Recall News (press release)

TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) announces the acceptance of two posters highlighting the clinical benefits of NATESTO for presentation at the Endocrine Society 2017 Annual Meeting (ENDO) to be held on April 1-4, 2017 in Orlando, Florida. Both abstracts will also be published in future issues of Endocrine Reviews. Developed by Acerus, NATESTO is the first and only testosterone nasal gel available in Canada and the US indicated for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).1

The acceptance of these posters, in addition to the two abstracts accepted for presentation at the American Urology Association Annual Meeting announced last month, further expands the body of evidence in support of NATESTO, said Tom Rossi, Chief Executive Officer of Acerus Pharmaceutical Corporation.

The following summarizes the two abstracts accepted for presentation at ENDO:

Title: Seasonal Allergies Do Not Significantly Impact the Absorption of NATESTO (Testosterone) Nasal Gel in Hypogonadal Men Abstract-ID: 32092 Presenter: Alan Rogol, MD, PhD, Professor, University of Virginia, Charlottesville, VA Conclusions: The pharmacokinetics, safety and efficacy of NATESTO for restoring normal testosterone levels in men with Low T is not adversely affected by seasonal allergies.

Title: One-Year Hematologic Safety of NATESTO (Testosterone) Nasal Gel in Men with Hypogonadism Abstract-ID: 32161 Presenter: Margaux Guidry, Ph.D. and Gerwin Westfield, Ph.D., both Aytu Bioscience, Englewood, CO Conclusions: Treatment with NATESTO helped hypogonadal men achieve normal testosterone levels, while on average keeping hematologic levels, particularly hematocrit, well within the normal range.

About NATESTO(Testosterone) Nasal Gel

NATESTO is a testosterone nasal gel developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. FDA and Health Canada, and available in a no-touch dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg. A copy of the NATESTO product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO/default.aspx.

For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO.com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.

Acerus currently markets two products in Canada: ESTRACE,a product indicated for the symptomatic relief of menopausal symptoms; and NATESTO, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism. Acerus pipeline includes two new innovative products: GYNOFLOR, an ultra-low dose vaginal estrogen combined with a probiotic, used in the treatment of atrophic vaginitis, restoration of vaginal flora and treatment of certain vaginal infections; and TEFINA, a use as required drug development candidate, aimed at addressing a significant unmet need for women with female sexual dysfunction.

For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice regarding forward-looking statements

Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 1, 2016 that is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

References:

1. NATESTO Product Monograph, October 25, 2016 and Rogol et al. J Andrology 2015, 4(1), 46

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Posters to Be Presented at the Endocrine Society 2017 Annual Meeting - Business Wire (press release)

Male hypogonadism is the result of deficiency of the male sex hormone testosterone. It leads to loss of sex drive and function, delayed puberty, osteoporosis, and there can also be associated failure of the testes to produce sperm.

Testosterone deficiency syndrome; testosterone deficiency; primary hypogonadism; secondary hypogonadism; hypergonadotrophic hypogonadism; hypogonadotrophic hypogonadism.

Male hypogonadism describes a state of low levels of the male hormone testosterone in men. Testosterone is produced in the testes and is important for the formation of male characteristics such as deepening of the voice, development of facial and pubic hair and growth of the penis and testes during puberty. Gonadotrophin-releasing hormone made in the hypothalamus stimulates the pituitary gland to produce luteinising hormone and follicle stimulating hormone (gonadotrophins), which then act on the testes causing them to produce testosterone.Low levels of testosterone can occur due to disease of the testes or from conditions affecting the hypothalamus or pituitary gland. Men can be affected at any age and present with different symptoms depending on the timing of the disease in relation to the start of puberty.

Male hypogonadism can be divided into two groups.Classical hypogonadism is where the low levels of testosterone are caused by an underlying specific medical condition, for example Klinefelter's syndrome, Kallmanns syndrome or a pituitary tumour.Late-onset hypogonadism is where the decline in testosterone levels is linked to general ageing and/or age-related diseases, particularly obesity.It is estimated that late-onset hypogonadism only affects a small number of men over the age of 40.

There are two types of classical male hypogonadism primary and secondary.Primary hypogonadism occurs when the low level of testosterone is due to conditions affecting the testes.Primary hypogonadism is also referred to as hypergonadotrophic hypogonadism, whereby the pituitary produces too much luteinising hormone and follicle stimulating hormone (gonadotrophins) to try and stimulate the testes to produce more testosterone. However, as the testes are impaired or missing, they are not able to respond to the increased levels of gonadotrophins and little or no testosterone is produced.

Examples of conditions affecting the testes, which lead to low levels of testosterone, include:

Secondary hypogonadism results from conditions affecting the function of the hypothalamus and/or pituitary gland.It is also known as hypogonadotrophic hypogonadism due to low levels of luteinising hormone and follicle stimulating hormone resulting in decreased testosterone production.Secondary hypogonadism often occurs as part of a wider syndrome of hypopituitarism.Examples of causes can include:

The signs and symptoms depend on the stage at which the patient presents with hypogonadism in relation to sexual maturity.If testosterone deficiency occurs before or during puberty, signs and symptoms are likely to include:

Around the time of puberty, boys with too little testosterone may also have less than normal strength and endurance, and their arms and legs may continue to grow out of proportion with the rest of their body.

In men who have already reached sexual maturity, symptoms are likely to include:

As some of these symptoms (e.g. tiredness, mood changes) can have multiple causes, diagnosis of male hypogonadism may sometimes get missed initially.

Male hypogonadism is more common in ageing men. The levels of testosterone in men start to fall after the age of 40. It has been estimated that 8.4% of men aged 50-79 years have testosterone deficiency.Male hypogonadism is also linked with type 2 diabetes: approximately 17% of men with type 2 diabetes are estimated to have low testosterone levels.

Male hypogonadism does not run in families.There are genetic causes of hypogonadism which include Klinefelters syndrome and Kallmanns syndrome; however, these conditions occur sporadically, they are not inherited from the parents.

A detailed medical history should be taken.In particular, it is important to find out if virilisation was complete at birth, whether the testes descended and to see if the patient went through puberty at the same time as his peers. The patient should be thoroughly examined and the presence and size of the testes recorded and whether they are correctly positioned in the scrotum.

Many of the symptoms of male hypogonadism are non-specific and can be caused by a range of conditions. Therefore, when diagnosing hypogonadism, it is important that biochemical tests are performed to assess the levels of testosterone in the blood to confirm diagnosis. Blood tests will be carried out to measure testosterone levels.The blood sample should be collected preferably at 9am (this is because levels of testosterone change throughout the day) and can be carried out as an outpatient appointment.If the result of the first test shows a low level of testosterone, the test should be repeated after two or three weeks to confirm the result. Other hormones are also tested along with the second blood sample. These hormones include luteinising hormone, follicle stimulating hormone and prolactin (produced by the pituitary gland).The results of these blood tests will help distinguish between primary (low testosterone and high gonadotrophins) and secondary (low testosterone and normal or low gonadotrophins) hypogonadism.

Depending on the findings of the above tests, other investigations may be carried out. These include: a bone densitometry test to assess the impact of testosterone deficiency on bone; semen analysis; genetic studies; and an ultrasound of the testes to check for nodules or growths.

Treatment of classical hypogonadism involves replacement of testosterone with the aim of raising the level of testosterone in the blood to normal levels.Exact treatment will vary between patients and be tailored to their individual needs.Different preparations of testosterone are available:

All these are outpatient treatments. All of these options should be discussed with a medical professional and the most appropriate treatment option chosen.During treatment with testosterone replacement, regular blood tests should be carried out to monitor testosterone levels and if necessary, the dose adjusted to ensure levels return to the normal range.Tablet forms of testosterone taken by mouth are not recommended due to a link with liver damage.

Testosterone should not be given if the patient has prostate cancer. Before starting treatment with testosterone, a blood test to measure a hormone produced by the prostate called PSA (prostate-specific antigen) is carried out (PSA levels are elevated in prostate cancer).The prostate may also be examined (via the back passage) to rule out prostate cancer.

For patients who have been diagnosed with late-onset hypogonadism, there is currently not enough evidence for us to know whether treatment with testosterone is safe and effective over the long-term.While there are some short-term studies that indicate it may benefit these patients over a short period of time, there is a need for longer-term clinical trials in this area, following a large number of patients, to assess the long-term impact of testosterone treatment on patients with late-onset hypogonadism. Areas that particularly require focus are assessing the effects of treatment on the likelihood of developing cardiovascular disease, prostate cancer and secondary polycythaemia (a condition where too many red blood cells are present in the blood).

If patients have any concerns about their health, they should contact their GP in the first instance.

There can be mild side-effects of testosterone replacement depending on the form used: injectable forms can cause pain and bruising at site of injection; the gel form can cause skin irritation; and the buccal form can cause gum irritation.

Treatment with testosterone can cause an increase in red blood cells (known as polycythaemia) which increases the risk of thrombosis.Regular blood tests should be carried out during treatment to check for an increase in red blood cells.Enlargement of the prostate is another serious side-effect that should be monitored.Prostate examination and a blood test for PSA should be performed every three months for the first year and then annually in men over the age of 40 years after starting treatment.If patients have any concerns about these possible side-effects, they should discuss them with their doctor.

Symptoms of male hypogonadism such as lack of sex drive, inadequate erections and infertility can lead to low self-esteem and cause depression. Professional counselling is available to help deal with these side-effects; patients should talk to their doctor for more information.Patients generally see an improvement in their sex drive and self-esteem following testosterone replacement therapy.

Male hypogonadism has been linked with an increased risk of developing heart disease (low testosterone can cause an increase in cholesterol levels). Studies have shown that testosterone levels can be lower in men with type 2 diabetes and in men with excess body weight.Lifestyle changes to reduce weight and increase exercise can raise testosterone levels in men with diabetes.

Testosterone levels in men decline naturally as they age.In the media, this is sometimes referred to as the male menopause (andropause).Low testosterone levels can also cause difficulty with concentration, memory loss and sleep difficulties.Current research suggests that this effect occurs in only a small group of ageing men.However, there is a lot of research in progress to find out more about the effects of testosterone in older men and also whether the use of testosterone replacement therapy would have any benefits.

Reviewed: December 2014

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You & Your Hormones | Endocrine conditions | Male hypogonadism

Solutions for less moustache and Beard growth

I am 21, but I dont have enough moustache and beard d in my face, how to grow it up, is there any medicines for it? My friends tease me.

I scared of getting married since my moustache and beard not developed. Would it affect my personal life?

Normally boys show their growth between the ages of 13 to 16 years. The secondary sexual characters like hair growth, starts from above the upper lip, chin and body. Only the sexual hormones bring these changes. Serum Testosterone is the authority for Masculine features. How Moustache and Beard develope?

Normally when the boy attains puberty, possible between ages of 13 to 16 years, the hair growth starts from above the upper lip, chin and body. This happens when the male sex hormone Testosterone is secreted from the testes. When a boy attains puberty, a centre in the brain called Hypothalamus, stimulates the Pituitary gland, which secretes two important hormones. The FSH ( Follicular stimulating hormone) stimulate the special cells in the Testes to produce sperms and the another hormone LH ( Luetinizing Hormone) stimulates the special cells to secretes the testosterone hormone. Testosterone is responsible for sudden growth in males with good musculature and bone density . The changes would lead to deepening in voice and enlargement of penis

Hair grows from hair follicles within the skin. There are about 50 million hair follicles covering the body of which one fifth is located in the scalp. Only the soles and palms are free of hair follicles. As long as follicles are not destroyed, hair continues to grow even if it is plucked, depilated or removed in any other fashion.

Various hormones control hair growth. Thyroid hormone and growth hormone affects hair growth. The most important hormone controlling growth are "androgens" commonly known as male hormones. Except in the scalp, androgens cause hair to change from "vellus" to "terminal". All women have terminal hair in some parts of the body, specifically the scalp, pubic and axillary area. A few hairs around the nipple or over the thighs may be normal. Hirsutism or excess body hair in women is the presence of thick, dark hair over the face, chest, abdomen, upper thighs or upper arms. It occurs when the androgenic hormone rises in some conditions.

The most important is Testosterone, one of a group of hormones called Androgens, which are responsible for "male" characteristics such as hair patterns and deeper voices. Hirsutism occurs when hair follicles become unusually sensitive to normal androgen levels in the blood, or when Androgen levels rise.

Every boy has same number of soft light colored hair on face in beard moustache area and other part of body. These are called vellus hair they are soft and light in colour , so that they are less easily visible. At the time of puberty and. beginning of genital development male hormone testosterone act on the various sensors in the hair roots of face and other parts of body. The blood supply in the hair root increases and hair grow from each follicle resulting in faster, darker and stronger hair. Thus in normal boys in two to three years full beard and moustache develops. When serum testosterone falls down the hair follicle fails or shows less growth

The vellus hair becomes dark terminal hair like our scalp hair and also appearance of hairs in pubis and armpits.

Testosterone is absolutely essential to maintain typical male features such as growth of beard and moustache, maintenance of bone and muscle strength, energy, and positive effect on mood, sperm production and sexual drive. Serum Testosterone is the authority for Masculine features.

Symptoms of Male Hypogonadism

Besides the retarded growth, there are many different symptoms of male hypogonadism. Coexists depend on the stage of life at which they occur. Symptoms during fetal development will differ from symptoms during puberty and adulthood

When the secretion falls down the youngsters may from

When the secretion falls downan adult may from

Retarded moustache , beard

Gynaecomastia

What Causes Male Hypogonadism?

Male Hypogonadism is caused by either an abnormality of the testicles or a defect in the pituitary gland. Hypothalamic dysfunction also encountered in many cases. Youngsters Testes fail to secrete Testosterone, when it has some congenital defects, following an infection such as mumps, other endocrine dysfunctions and tumours. Normally an adult, at the age of forty years may have reduced secretion. Sometimes smoking, alcoholism drugs and general diseases may enhance it. Even emotions may predispose.

There are few case in which the f hair roots resistant to normal level of testeosterone and its allied hormones. In this condition the hair roots do not grow because in hair root there is less male hormone receptor so that male hormone is unable to work and hair do not grow well.

How to rectify?

Homoeopathy finds solution to the problem successfully in many cases. The imaging study for Testes and brain will rule out the Endocrine pathology. A blood study on hormone will locate the problem. Unlike other systems of medicine Homoeopathy wont replace the hormones by a medicine; indeed it is applied naturally in dynamic doses to stimulate the blockage at the cellular level.

It is possible to maintains the axis equally between the Hypothalamus, pituitary and testicular functions to regenerate the testosterone level. The hair apparatus sensitivity could be enhanced by the dynamic application of the Homoeopathic remedies top respond The clinical studies had shown excellent results in the growth of Moustache, Beard, Erectile dysfunction and Infertility, due to low production of sperms Many cases had been demonstrated with blood study also scientifically.

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Hypogonadism No Moustache! No Beard

Hypergonadotropic hypogonadism (HH), also known as primary or peripheral/gonadal hypogonadism, is a condition which is characterized by hypogonadism due to an impaired response of the gonads to the gonadotropins, follicle-stimulating hormone (FSH) and luteinizing hormone (LH), and in turn a lack of sex steroid production and elevated gonadotropin levels (as an attempt of compensation by the body). HH may present as either congenital or acquired, but the majority of cases are of the former nature.[1][2]

There are a multitude of different etiologies of HH. Congenital causes include the following:[1][3][4]

Acquired causes (due to damage to or dysfunction of the gonads) include ovarian torsion, vanishing/anorchia, orchitis, premature ovarian failure, ovarian resistance syndrome, trauma, surgery, autoimmunity, chemotherapy, radiation, infections (e.g., sexually-transmitted diseases), toxins (e.g., endocrine disruptors), and drugs (e.g., antiandrogens, opioids, alcohol).[1][3][4]

Examples of symptoms of hypogonadism include delayed, reduced, or absent puberty, low libido, and infertility.

Treatment of HH is usually with hormone replacement therapy, consisting of androgen and estrogen administration in males and females, respectively.[3]

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Hypergonadotropic hypogonadism - Wikipedia

Hypogonadism means diminished functional activity of the gonadsthe testes in males or the ovaries in femalesthat may result in diminished sex hormone biosynthesis. In layman's terms, it is sometimes called interrupted stage 1 puberty. Low androgen (e.g., testosterone) levels are referred to as hypoandrogenism and low estrogen (e.g., estradiol) as hypoestrogenism, and may occur as symptoms of hypogonadism in both sexes, but are generally only diagnosed in males and females respectively. Other hormones produced by the gonads that hypogonadism can decrease include progesterone, DHEA, anti-Mllerian hormone, activin, and inhibin. Spermatogenesis in males, and ovulation in females, may be impaired by hypogonadism, which, depending on the degree of severity, may result in partial or complete infertility.

Deficiency of sex hormones can result in defective primary or secondary sexual development, or withdrawal effects (e.g., premature menopause) in adults. Defective egg or sperm development results in infertility. The term hypogonadism usually means permanent rather than transient or reversible defects, and usually implies deficiency of reproductive hormones, with or without fertility defects. The term is less commonly used for infertility without hormone deficiency. There are many possible types of hypogonadism and several ways to categorize them. Hypogonadism is also categorized by endocrinologists by the level of the reproductive system that is defective. Physicians measure gonadotropins (LH and FSH) to distinguish primary from secondary hypogonadism. In primary hypogonadism the LH and/or FSH are usually elevated, meaning the problem is in the testicles, whereas in secondary hypogonadism, both are normal or low, suggesting the problem is in the brain.

Hypogonadism can involve just hormone production or just fertility, but most commonly involves both.

Women with hypogonadism do not begin menstruating and it may affect their height and breast development. Onset in women after puberty causes cessation of menstruation, lowered libido, loss of body hair and hot flashes. In boys it causes impaired muscle and beard development and reduced height. In men it can cause reduced body hair and beard, enlarged breasts, loss of muscle, and sexual difficulties. A brain tumor (central hypogonadism) may involve headaches, impaired vision, milky discharge from the breast and symptoms caused by other hormone problems.[3]

The symptoms of hypogonadotrophic hypogonadism, a subtype of hypogonadism, include late, incomplete or lack of development at puberty, and sometimes short stature or the inability to smell; in females, a lack of breasts and menstrual periods, and in males a lack of sexual development, e.g., facial hair, penis and testes enlargement, deepening voice.

Low testosterone can be identified through a simple blood test performed by a laboratory, ordered by a physician. This test is typically ordered in the morning hours, when levels are highest, as levels can drop by as much as 13% during the day.[4]

Normal total testosterone levels range from 240950ng/dL (nanograms per decilitre)[5]

Treatment is often prescribed for total testosterone levels below 230ng/dL.[6] If the serum total testosterone level is between 230 and 350ng/dL, repeating the measurement of total testosterone with sex hormone-binding globulin (SHBG) to calculate free testosterone or free testosterone by equilibrium dialysis may be helpful.

The standard range given is based off widely varying ages and, given that testosterone levels naturally decrease as humans age, age-group specific averages should be taken into consideration when discussing treatment between doctor and patient.[7] In men, testosterone falls approximately 1 to 3 percent each year.[8]

A position statement by The Endocrine Society expressed dissatisfaction with most assays for TT (Total Testosterone) and FT (Free Testosterone).[9] In particular, research has questioned the validity of commonly administered assays of FT by RIA.[9] The FAI (Free Androgen Index) has been found to be the worst predictor of Free Testosterone.[10]

Similar to men, the LH and FSH is used, particularly in women who believe they are in menopause. These levels change during a woman's normal menstrual cycle, so the history of having ceased menstruation coupled with high levels aids the diagnosis of being menopausal. Commonly, the post-menopausal woman is not called hypogonadal if she is of typical menopausal age. Contrast with a young woman or teen, who would have hypogonadism rather than menopause. This is because hypogonadism is an abnormality, whereas menopause is a normal change in hormone levels.

Hypogonadism is often discovered during evaluation of delayed puberty, but ordinary delay, which eventually results in normal pubertal development, wherein reproductive function is termed constitutional delay. It may be discovered during an infertility evaluation in either men or women.

Male hypogonadism is most often treated with testosterone replacement therapy (TRT) in patients who are not trying to conceive.[citation needed] Adverse effects of testosterone replacement therapy include increased cardiovascular events (including strokes and heart attacks) and deaths.[11] The Food and Drug Administration (FDA) stated in 2015 that neither the benefits nor the safety of testosterone have been established for low testosterone levels due to aging.[12][13] The FDA has required that testosterone pharmaceutical labels include warning information about the possibility of an increased risk of heart attacks and stroke.[12][13]

Commonly used testosterone replacement therapies include transdermal (through the skin) using a patch or gel, injections, or pellets. Oral testosterone is no longer used in the U.S. because it is broken down in the liver and rendered inactive; it also can cause severe liver damage.[citation needed] Like many hormonal therapies, changes take place over time. It may take as long as 23 months at optimum level to reduce the symptoms, particularly the wordfinding and cognitive dysfunction.[citation needed] Testosterone levels in the blood should be evaluated to ensure the increase is adequate. Levels between 400 and 700ng/dL are considered appropriate mid-dose levels. Treatment usually starts with 200mg intramuscular testosterone, repeated every 14 days.[citation needed]

While historically, men with prostate cancer risk were warned against testosterone therapy, that has shown to be a myth.[14]

Other side effects can include an elevation of the hematocrit to levels that require blood withdrawal (phlebotomy) to prevent complications from "too thick" blood. Another is that a man may have some growth in the size of the breasts (gynecomastia), though this is relatively rare. Finally, some physicians worry that Obstructive Sleep Apnea may worsen with testosterone therapy, and should be monitored.[15]

Another feasible treatment alternative is human chorionic gonadotropin (hCG).[16]

For both men and women, an alternative to testosterone replacement is Clomifene treatment, which can stimulate the body to naturally increase hormone levels while avoiding infertility and other side effects that can result from direct hormone replacement therapy.[17]

For men, Aquaviron injections may be useful.

For women, estradiol and progesterone are replaced. Some types of fertility defects can be treated, others cannot. Some physicians also give testosterone to women, mainly to increase libido.[citation needed]

Originally posted here:
Hypogonadism - Wikipedia

Rev Urol. 2004; 6(Suppl 6): S3S8.

Auxilium Pharmaceuticals, Inc., Norristown, PA

Hypogonadism can be of hypothalamic-pituitary origin or of testicular origin, or a combination of both, which is increasingly common in the aging male population. In the postpubertal male, testosterone replacement therapy can be used to treat the signs and symptoms of low testosterone, which include loss of libido, erectile dysfunction, diminished intellectual capacity, depression, lethargy, osteoporosis, loss of muscle mass and strength, and some regression of secondary sexual characteristics. Before initiation of testosterone replacement therapy, an examination of the prostate and assessment of prostate symptoms should be performed, and both the hematocrit and lipid profile should be measured. Absolute contraindications to testosterone replacement therapy are prostate or breast cancer, a hematocrit of 55% or greater, or sensitivity to the testosterone formulation.

Key words: Hypogonadism, Testosterone replacement therapy, Serum hormone-binding globulin, Luteinizing hormone, Follicle-stimulating hormone

Hypogonadism is a lack of testosterone in male patients and can be of central (hypothalamic or pituitary) or testicular origin, or a combination of both. Hypogonadism in male patients with testicular failure due to genetic disorders (eg, Klinefelters syndrome), orchitis, trauma, radiation, chemotherapy, or undescended testes, is known as hypergonadotropic hypogonadism or primary hypogonadism. Hypogonadism in male patients with gonadotropin deficiency or dysfunction as a result of disease or damage to the hypothalamic-pituitary axis is known as hypogonadotropic hypogonadism, central hypogonadism, or secondary hypogonadism. This might be due to Kallmanns syndrome, tumor, trauma, radiation, sarcoidosis, or tuberculosis. In addition, men older than 50 years might have low testosterone levels with functional abnormalities at multiple levels of the hypothalamic-pituitary-testicular axis.1,2,3

The prevalence of hypogonadism has increased in recent years. It has been reported that 12%, 19%, 28%, and 49% of men greater than 50, 60, 70, or 80 years of age, respectively, fit the criteria of hypogonadism.4

During puberty, testosterone is required for the development of male secondary sexual characteristics, stimulation of sexual behavior and function, and initiation of sperm production.5,6 In adult males, testosterone is involved in maintaining muscle mass and strength, fat distribution, bone mass, red blood cell production, male hair pattern, libido and potency, and spermatogenesis.13,5,6

In men, the major gonadal steroid hormone is testosterone. Testosterone circulates in 3 major forms: unbound, or free, testosterone; tightly bound testosterone, which is bound to sex hormone-binding globulin (SHBG); and weakly bound testosterone, which is bound to albumin. Only free and weakly bound testosterone is bioavailable or able to bind to the androgen receptor.2,3

In males, serum testosterone levels show a circadian variation, with the highest levels in the morning and lowest levels in the late afternoon. In young men, the variation in testosterone levels is approximately 35%. Although the normal range for serum testosterone might vary between different laboratories, the normal range for early morning total testosterone in healthy adult males is approximately 300 ng/dL to 1000 ng/dL.7,8

To determine whether a patient is testosterone deficient, a clinician must consider clinical signs and symptoms in conjunction with laboratory values. The initial clinical picture will vary depending on the age of the patient at the onset of the disorder.

In the normal male, the start of puberty is apparent by enlargement of the testes and the appearance of pubic hair, followed by the appearance of auxiliary and facial hair. At puberty there is also increased penile length and the onset of spermatogenesis. If signs of puberty are not evident in boys by 14 years of age, a workup for delayed puberty is warranted.

In the prepubertal age group, hypogonadism might be either primary hypogonadism or secondary hypogonadism. To differentiate primary from secondary hypogonadism, early morning luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels must be obtained. Because LH and FSH are secreted during the early morning at the beginning of puberty, it is necessary to measure these hormones in the early morning (8:0010:00 AM). Primary hypogonadism is associated with low levels of testosterone and high-normal to high levels of LH and FSH. Secondary hypogonadism is associated with low levels of testosterone and normal to low levels of LH and FSH.5,6

The signs and symptoms of low testosterone in postpubertal adult males can be more difficult to diagnose and might include loss of libido, erectile dysfunction, diminished intellectual capacity, depression, lethargy, osteoporosis, loss of muscle mass and strength, and some regression of secondary sexual characteristics.13 At the initial visit, the first objective is to distinguish between primary gonadal failure, in which low testosterone is accompanied by increased FSH and increased LH, and hypothalamic-pituitary disorders (secondary hypogonadism), with low testosterone and low to normal FSH and LH levels.

Initial laboratory testing should include early morning (8:0010:00 AM) measurement of serum testosterone, prolactin, FSH, and LH levels. For the diagnosis of primary hypogonadism, FSH measurement is particularly important because FSH has a longer half life, is more sensitive, and demonstrates less variability than LH.2,3

The aging male patient can present with signs and symptoms of low testosterone, including loss of libido, erectile dysfunction, diminished intellectual capacity, depression, lethargy, osteoporosis, and loss of muscle mass and strength.13 At the initial visit, laboratory testing should include early morning (8:0010:00 AM) measurement of serum testosterone. In elderly men, testosterone levels decrease between 15% and 20% over the course of 24 hours.8

Total testosterone levels might be normal with hypogonadism if the SHBG levels are increased.79 Levels of SHBG increase with age, causing a decrease in bioavailable testosterone.9 If testosterone levels are low-normal but the clinical symptoms and signs indicate hypogonadism, measurement of serum total testosterone levels should be repeated and an SHBG level should be determined. With the total testosterone and SHBG levels, a bioavailable testosterone value can be calculated. A bioavailable testosterone calculator is available at http://www.issam.ch/freetesto.htm.

It is usually not necessary to determine FSH or LH levels in the aging male.

It is well accepted that testosterone levels should be measured in the early morning, when they are at their peak level. However, in community practice the choice of which testosterone parameter to measure is still debatable.

Total testosterone assay is widely available and inexpensive to perform. Although the ranges and methods vary, physicians can consult their local laboratories for the applicable values in their clinical practice. Total testosterone values, however, must be interpreted carefully in the aging male because SHBG levels might be elevated. If the total testosterone level is normal in the aging male presenting signs of hypogonadism, the clinician can measure free testosterone or measure SHBG and calculate bioavailable testosterone.9

Free testosterone can be measured by equilibrium dialysis or ultrafiltration, which are difficult to perform and largely unavailable but reliable. In contrast, the radioimmunoassay for free testosterone is widely available but unreliable. Because total testosterone and SHBG assays are readily available and cheap, calculating bioavailable testosterone might be a good compromise. Whichever method is chosen, if the early morning testosterone level is at or below the lower limit of normal for the individual laboratory, then a repeat measurement of the early morning testosterone level should be performed to confirm the result. Because testosterone is secreted in a pulsatile fashion, it is important to obtain 2 early morning testosterone levels.

In selected patients, FSH, LH, and prolactin can be measured. If the FSH and LH levels are raised, this suggests a primary testicular cause, and if levels are low or normal, a hypothalamic or pituitary cause should be considered. A raised prolactin level suggests that further investigation of the pituitary gland should be undertaken.1,2

The clinical signs and symptoms of hypogonadism will vary depending on whether the patient presents before or after puberty. Depending on the age of the patient, the degree of pubertal development is important for establishing the differential diagnosis.

Boys aged 14 years or older should be suspected of being hypogonadal if on examination they have underdeveloped testes, lack of penile enlargement, and absence of pubic, auxiliary, and facial hair.

In patients with primary hypogonadism, history might reveal the cause for primary testicular failure, such as familial autoimmune disease, physical trauma to the testes, or trauma to the testes caused by radiation, chemotherapy, or infection.

A karyotype should be obtained to diagnose chromosomal abnormalities, such as Klinefelters syndrome, and a physical examination will reveal small or absent testes resulting from anorchia, Noonans syndrome, or other testicular disorders.

Hypothalamic or pituitary deficiency might be transitory or permanent. Transient secondary hypogonadism might be related to malnutrition or stress states and can be diagnosed by physical examination and evaluation of the patients growth chart. If permanent hypothalamic or pituitary hormone deficiency is suspected, serum levels of pituitary hormones and magnetic resonance imaging of the brain and pituitary should be obtained to screen for hypothalamic or pituitary disease.

If both physical examination and serum chemistry tests are normal, then by exclusion a diagnosis of constitutional pubertal delay must be considered.

To establish a diagnosis of hypogonadism, it is important to take a careful history to determine whether there have been major medical problems, toxic exposure, concomitant drug therapy that might cause hypogonadism, or fertility problems.

Low libido, impotence, fatigue, impaired concentration, and sexual dysfunction are important clinical problems that might not be raised by the patient in the clinic. Therefore, these symptoms need to be asked about specifically if hypogonadism is suspected.13

Formal assessment of intellectual changes, mood, and cognitive changes can be performed. Changes in lean body mass will be apparent from the medical history and examination, as will changes in hair, skin, and fat distribution. Decreases in bone mineral density might be apparent from a history of recent fractures but can only be confirmed by dual energy x-ray absorptiometry (DEXA).1

Physical examination should include testicular examination, including size and consistency. The distribution and amount of body hair should also be noted. Penile size is not affected by postpubertal testosterone deficiency. An assessment of the prostate by digital rectal examination (DRE) should be performed and a prostate-specific antigen (PSA) value obtained.3

To establish a diagnosis of hypogonadism in the aging male, it is important to assess the patient carefully for signs and symptoms. Low libido, impotence, fatigue, impaired concentration, and sexual dysfunction are important clinical problems that might not be raised by the patient in the clinic, especially by an aging patient. Therefore, as with the younger postpubertal patient, these symptoms need to be asked about specifically if hypogonadism is suspected.1,2 As with the postpubertal patient (see previous section), changes in intellectual functioning; mood; lean body mass; and hair, skin, and fat distribution should all be assessed, and DEXA can be used to confirm decreases in bone mineral density.1

In older patients, an important part of the physical examination includes an assessment of the prostate by DRE and PSA assay. In addition, an assessment of prostate-related symptoms should be undertaken. The presence of gynecomastia or carcinoma of the breast are important physical findings.

In cases of primary and permanent secondary hypogonadism diagnosed in the prepubertal male, life long testosterone treatment is needed. The usual treatment is initiation of therapy with small doses of testosterone (50100 mg IM) every 3 to 4 weeks at the appropriate psychosocial stage in development. When a final adult height is thought to have been obtained, the adult dose of testosterone replacement is inaugurated.

In the postpubertal period, once the diagnosis of testosterone deficiency has been made, replacement therapy should be considered in light of the clinical signs and symptoms in conjunction with the laboratory values. The objective of testosterone replacement therapy is to normalize serum testosterone and maintain the level within the eugonadal state. In addition, treatment objectives might include improving sexual dysfunction, intellectual capacity, depression, and lethargy; maintaining bone mineral density and possibly reducing fracture risk; increasing muscle mass and strength; and enhancing the quality of life.13,9

Although the normal range for serum testosterone might vary between different laboratories, the normal range for early morning testosterone in male adults is approximately 300 ng/dL to 1000 ng/dL.7 An early morning total serum testosterone level of less than 300 ng/dL clearly indicates hypogonadism, and under most circumstances benefit will be derived from testosterone replacement therapy. A healthy male adult patient with a serum testosterone level greater than 400 ng/dL is unlikely to be testosterone deficient, and therefore clinical judgment should be exercised if he has symptoms suggestive of testosterone deficiency.

There are some absolute contraindications to testosterone replacement therapy. These include prostate cancer, which must be assessed by history and clinical examination. If on DRE the prostate is enlarged or if the PSA level is greater than 4.0 ng/mL, biopsy of the prostate should be undertaken to confirm a diagnosis of prostate cancer or benign prostatic hyperplasia (BPH).3

An existing or prior history of breast cancer is also an absolute contraindication to testosterone replacement therapy. Testosterone therapy is known to increase the hematocrit, and therefore a pre-existing hematocrit of 55% or greater is an absolute contraindication to replacement therapy.

Sensitivity to any of the ingredients in the testosterone formulation would also be an absolute contraindication. Relative contraindications include an increased hematocrit, untreated sleep apnea, severe obstructive symptoms of BPH, and advanced congestive cardiac failure.2,3

The goal of replacement therapy is to maintain testosterone in the normal physiological range; therefore, a combination of clinical and biochemical measures should be monitored 6 to 12 weeks after initiating therapy. In most cases, an early morning serum total testosterone level is adequate to determine whether dosage adjustment is necessary. However, patients receiving injections of testosterone enanthate or cypionate every 2 weeks will require an earlier measurement of serum testosterone at 1 to 2 weeks after commencement of therapy.3

Examination of the prostate should be performed routinely, although the exact frequency after initiation of testosterone replacement is still debatable. Digital rectal examination of the prostate and PSA assay should be performed before initiation of therapy, along with an assessment of prostate-related symptoms. In elderly men, a DRE and PSA assay should be performed at 3 and 6 months after commencing testosterone therapy and then annually thereafter.3 A high PSA level should be further evaluated with a highly specific PSA assay, if available. A patient should be referred to a urologist if his PSA level increases over time or if he has a PSA level greater than 4.0 ng/mL.3

It is known that testosterone stimulates bone marrow production of erythrocytes, which might result in an increased hematocrit in some men, and therefore this should be checked at the same time as the PSA level.2,3

Lipid disturbances in testosterone-treated male patients are generally not a problem because the ratio of high-density lipoprotein to total cholesterol usually remains constant. An initial lipid profile should be performed before therapy, and a follow-up profile should be obtained after 6 to 12 months of therapy and annually thereafter.3

Hypogonadism can be of hypothalamic-pituitary origin or of testicular origin, or a combination of both, which is increasingly common in the aging male population. It can be easily diagnosed with measurement of the early morning serum total testosterone level, which should be repeated if the value is low. Follicle-stimulating hormone, LH, and prolactin might also need to be measured. If the clinical signs and symptoms suggest hypogonadism but the serum testosterone level is near normal, then assay of serum testosterone should be repeated in conjunction with SHBG because serum testosterone might be normal in the presence of hypogonadism if the SHBG level is raised, which commonly occurs in elderly male patients.

Before initiation of testosterone replacement therapy, an examination of the prostate, including DRE, PSA assay, and assessment of prostate symptoms should be undertaken, and both the hematocrit and lipid profile should be measured. There are few absolute contraindications to testosterone replacement therapy other than prostate or breast cancer, a hematocrit of 55% or greater, or sensitivity to the testosterone formulation. Monitoring of the prostate (assessed with DRE and PSA assay) and hematocrit and lipid profile should be repeated during testosterone replacement therapy.

The benefits of testosterone replacement therapy may include restoring metabolic parameters to the eugonadal state; improving psychosexual function and intellectual capacity, including depression and lethargy; maintaining bone mineral density and reducing bone fractures; improving muscle mass and strength; and enhancing quality of life.

Hypogonadism is a lack of testosterone in male patients and can be of central (hypothalamic or pituitary) or testicular origin, or a combination of both.

Boys ages 14 years or older should be suspected of being hypogonadal if on examination they have underdeveloped testes, a lack of penile enlargement, and an absence of pubic, auxiliary, and facial hair.

In pre- and postpubertal male patients, primary hypogonadism is associated with low levels of testosterone and high-normal to high levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH); secondary hypogonadism is associated with low levels of testosterone and normal to low levels of LH and FSH.

In the aging male patient, signs and symptoms of hypogonadism can include loss of libido, erectile dysfunction, diminished intellectual capacity, depression, lethargy, osteoporosis, and loss of muscle mass and strength.

For aging men, laboratory testing should include early morning (8:0010:00 AM) measurement of serum testosterone; levels less than 300 ng/dL clearly indicate hypogonadism, and under most circumstances benefit will be derived from testosterone replacement therapy.

Before initiation of testosterone replacement therapy, an examination of the prostate and assessment of prostate symptoms should be performed, and both the hematocrit and lipid profile should be measured.

There are few absolute contraindications to testosterone replacement therapy other than prostate or breast cancer, a hematocrit of 55% or greater, or sensitivity to the testosterone formulation.

1. AACE Hypogonadism Task Force. Endocr Pract. 2002;8:439456.

5. Griffin JE, Wilson JD. Endocrinology & Metabolism. 15th Ed. Vol. 335. New York, NY: McGraw Hill; 2001. Disorders of the testes. Harrisons principles of internal medicine; pp. 21432154.

6. Beers MH, Berkow R, editors. The Merck Manual of Diagnosis and Therapy. 17th ed. New York, NY: John Wiley & Sons; 1999.

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Diagnosis of Hypogonadism: Clinical Assessments and ...

Hypogonadism is a medical term for a defect of the reproductive system which results in lack of function of the gonads (ovaries or testes).

Hypogonadism may occur if the hypothalamic-pituitary-gonadal axis is interrupted at any level. Hypergonadotropic hypogonadism (primary hypogonadism) results if the gonad does not produce the amount of steroid sufficient to suppress secretion of LH and FSH at normal levels. Hypogonadism resulting from defects of the gonads is traditionally referred to as primary hypogonadism. Examples include Klinefelter syndrome and Turner syndrome. Hypogonadism resulting from hypothalamic or pituitary defects are termed secondary hypogonadism or central hypogonadism (referring to the central nervous system). Hypogonadism can affect men of any age, from fetal development, through puberty and adulthood. Hypogonadism is one of the main causes of male infertility. It is estimated that 13 million men in the United States alone are affected by hypogonadism. Hypogonadism is caused by deficient testosterone secretion by the testes. The two basic types of male hypogonadism are Primary and Secondary.

Hypogonadism Primary, also known as primary testicular failure, originates from an abnormality in the testicles. Hypogonadism may be induced by chronic use of anabolic/androgenic steroids (AAS). The Secondary type of hypogonadism is caused by defects in the pituitary gland connected to the brain that controls hormone production. If chemical messages from the pituitary gland to the testicles aren't sent, impaired testicular function occurs. This condition can be a result from defects in development of the pituitary gland, certain inflammatory diseases, and the use of certain drugs used in the treatment of psychiatric disorders and gastroesophageal reflux disease. Mental and emotional changes can also accompany hypogonadism. As testosterone decreases, some men may experience signs and symptoms similar to those of menopause in women. These may include hot flashes, decreased drive, irritability, depression and fatigue.

Hypogonadism is most often treated by replacement of the appropriate hormones.

Gonadotropin or GnRH replacement is offered to the patient when fertility is desired. Oral testosterone is no longer used in the U.S. because it is broken down in the liver and rendered inactive. In boys, testosterone replacement therapy (TRT) can stimulate puberty and the development of secondary characteristics, such as increased muscle mass, beard and pubic hair growth. Also available is a topical 1% testosterone gel. It is applied once daily to clean, dry skin of the shoulders, upper arms, or abdomen. Another alternative is testosterone patches. The testosterone may be mixed with the adhesive with a new patch applied daily to a different site; this system leaves a sticky residue but causes little skin irritation. Injections of pituitary hormone may be used to help male patients produce sperm. In others, surgery and radiation therapy may be needed. In adult men, TRT can restore function and muscle strength and prevent bone loss.

Treatment for Hypogonadism

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Hypogonadism - Definition, Causes, Symptoms and Treatment

Testosterone deficiency is frequently seen in both men and women with HIV. Endocrine abnormalities, which can affect testosterone production, have long been recognized as a complication of HIV since the earliest days of the pandemic (although it has generally been associated with late stage disease).

However, recent research has shown that nearly one out of every five men with HIV has documented testosterone deficiency, irrespective of CD4 count, viral load, or treatment status.

Similarly, testosterone deficiency is seen in one in four HIV-positive women, most often in the context of severe, unexplained weight loss (HIV wasting).

Testosterone is the steroid hormone which is central to the development of the testes (testicles) and prostate in men as well as the promotion of secondary male sexual characteristics (e.g., lean muscle mass, bone mass, hair growth). Testosterone is also important to women in maintaining normal muscle and bone mass, although at levels around 10% less than men.

In both men and women, testosterone is essential to a person's overall health and well-being, contributing to an individual's strength, energy levels, and libido.

By contrast, testosterone depletion is associated with:

Testosterone deficiency in men with HIV is largely associated with an endocrine abnormality called male hypogonadism in which the function of the male gonads (testes) is impaired, resulting in the diminished production of sex hormones beyond what would be expected of a man's specific age.

In the general population, hypogonadism is known to occur in about one in 25 men between the ages of 30 and 50, increasing to one in 14 between the ages of 50 to 79. By contrast, the incidence among men with HIV is as much as five times greater.

Hypogonadism can be caused by either a defect in the testes themselves (primary) or a dysfunction occurring outside of the testes (secondary). In adult males with HIV:

Hypogonadism can also be caused by childhood mumps or the abuse of anabolic steroids. HIV medications have not been shown to contribute to hypogonadism.

Hypogonadism in adult males is characterized by low serum (blood) testosterone levels, as well as one or several of following symptoms:

Diagnosis is made by measuring the amount of testosterone in the blood, of which there are three different subtypes. When a test is performed, the results will reveal both a person's total testosterone (all subtypes) and one of the three subtypes called free testosterone.

Free testosterone is simply a type of testosterone to which no protein is attached, allowing it enter cells and activate receptors that other subtypes can't. It is considered the most accurate measure of testosterone deficiency, despite representing only 2-3% of the total population. On its own, total testosterone is considered less accurate since results can appear normal if other non-free subtypes are elevated.

Testing should be performed early in the morning since levels can fluctuate by up to 20% during the course of a day. "Normal" levels are simply those within the reference range of the lab. These ranges can vary, but, for illustrative purposes, are roughly between

However, an assessment of "normal" cannot be made by numbers alone. Testosterone levels tend to drop by about 1-2% every year after the age of 40. Therefore, what may be "normal" for a 60-year-old male won't be the same for a 30-year-old. Assessments need to be made on an individual basis with your treating doctor.

If a diagnosis of hypogonadism is confirmed, testosterone replacement therapy may be indicated. Intramuscular testosterone injections are usually recommended, which offer low side effects if physiological doses are used and adjusted by the treating doctor. FDA-approved options include Depo-testosterone (testosterone cypionate) and Delatestryl (testosterone enanthate).

On average, injections are given every two to four weeks. To avoid the effects of fluctuating testosterone levelswhich can cause sometimes dramatic swings in mood, energy, and sexual functionlower doses and shorter dosing intervals are often used.

Side effects of treatment can include:

Testosterone replacement therapy can also cause the acceleration of pre-existing prostate cancer. Because of this, a patient's prostate-specific antigen (PSA) levels will be tested and monitored during the course of therapy.

All told, intramuscular injections offer a cost-effective option for treating hypogonadism, with associative increases in alertness, well-being, libido, lean muscle mass, and erection ability. Disadvantages include regular doctor's visits and dosing administration.

Oral, transdermal, and topical gel agents are also available, and may be applicable in certain cases. Discuss these with your doctor.

In women, testosterone is produced in the ovaries and adrenal glands. As with men, it is an important hormone for maintaining normal muscle and bone mass, as well as energy, strength, and libido.

While hypogonadism is far less common in women with HIV, it can occur and is most often in the context of HIV wasting and advanced disease. The implementation of ART can reverse wasting and the hypogonadal state in many cases.

There are currently no fixed guidelines for the treatment of female hypogonadism, and treatment options are limited. Hormone replacement therapy (HRT) may be appropriate for some, while the short-term use of testosterone may improve sex drive, lean muscle mass, and energy levels.

However, data is still incomplete on the use of testosterone to treat hypogonadism in pre-menopausal women with HIV. Speak with your health care provider about possible side effects. Testosterone is not recommended for women who are pregnant or wish to become pregnant.

Rietschel, P.; Corcoran, C.; Stanley T.; et al. "Prevalence of hypogonadism among men with weight loss related to human immunodeficiency virus infection who were receiving highly active antiretroviral therapy." Clinical Infectious Diseases. November 2, 2000; 31(5):1240-1244.

Hugh Jones, T. "Late Onset Hypogonadism." British Medical Journal. February 13, 2009; 338:b352.

Huang, J.; Wilkie, S.; Dolan, S.; et al. "Reduced testosterone levels in human immunodeficiency virus-infected women with weight loss and low weight." Clinical Infectious Diseases. January 28, 2003; 36(4):499-506.

Grinspoon, S. "The Use of Androgens in HIV-Infected Men and Women." Physicians Research Network Notebook. March 2005.

Kalyani, R.; Gavini, S.; and Dobs. A. "Male Hypogonadism in systemic disease." Endocrinology Metabolism Clinics of North America Journal. June 2007; 36(2):333-48.

Carnegie, C. "Diagnosis of Hypogonadism: Clinical Assessment and Laboratory Tests." Review in Urology. 2004; 6(6):s3-8.

Kumar, P.; Kumar, N.; Patidar, A.; et al. "Male Hypogonadism: Symptoms and treatment." Journal of Advanced Pharmacological Technology and Research. July-September 2010; 1(3): 297-302.

Mylonakis, E.; Koutkia, P.; and Grinspoon, S. "Diagnosis and treatment of androgen deficiency in human immunodeficiency virus-infected men and women." Clinical Infectious Diseases. September 15, 2001; 33(6):857-64.

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HIV and Testosterone Deficiency - verywell.com

Definition

Hypogonadism occurs when the body's sex glands produce little or no hormones. In men, these glands (gonads) are the testes. In women, these glands are the ovaries.

Gonadal deficiency

The cause of hypogonadism can be primary or central. In primary hypogonadism, the ovaries or testes themselves do not function properly. Causes of primary hypogonadism include:

The most common genetic disorders that cause primary hypogonadism are Turner syndrome (in women) and Klinefelter syndrome (in men).

If you already have other autoimmune disorders you may be at higher risk of autoimmune damage to the gonads. These can include disorders that affect the liver and adrenal and thyroid glands as well as type 1 diabetes.

In central hypogonadism, the centers in the brain that control the gonads (hypothalamus and pituitary) do not function properly. Causes of central hypogonadism include:

A genetic cause of central hypogonadism is Kallmann syndrome. Many people with this condition also have a decreased sense of smell.

Girls who have hypogonadism will not begin menstruating. Hypogonadism can affect their breast development and height. If hypogonadism occurs after puberty, symptoms in women include:

In boys, hypogonadism affects muscle, beard, genital and voice development. It also leads to growth problems. In men the symptoms are:

If a pituitary or other brain tumor is present (central hypogonadism), there may be:

The most common tumors affecting the pituitary are craniopharyngioma in children and prolactinoma adenomas in adults.

You may need to have tests to check:

Other tests may include:

Sometimes imaging tests are needed, such as a sonogram of the ovaries. If pituitary disease is suspected, an MRI or CT scan of the brain may be done.

You may need to take hormone-based medicines. Estrogen and progesterone are used for girls and women. The medicines comes come in the form of a pill or skin patch. Testosterone is used for boys and men. The medicine can be given as a skin patch, skin gel, a solution applied to the armpit, a patch applied to the upper gum, or by injection.

For women who have not had their uterus removed, combination treatment with estrogen and progesterone may decrease the chance of developing endometrial cancer. Women with hypogonadism who have low sex drive may also be prescribed low-dose testosterone.

In some women, injections or pills can be used to stimulate ovulation. Injections of pituitary hormone may be used to help men produce sperm. Other people may need surgery and radiation therapy.

Many forms of hypogonadism are treatable and have a good outlook.

In women, hypogonadism may cause infertility. Menopause is a form of hypogonadism that occurs naturally and can cause hot flashes, vaginal dryness, and irritability as a woman's estrogen levels fall. The risk of osteoporosis and heart disease increase after menopause.

Some women with hypogonadism take estrogen therapy, especially those who have early menopause. But long-term used of hormone therapy can increase the risk of breast cancer, blood clots and heart disease. Women should talk with their health care provider about the risks and benefits of hormone replacement therapy with your doctor.

In men, hypogonadism results in loss of sex drive and may cause:

Men normally have lower testosterone as they age. However, the decline in hormone levels is not as dramatic as it is in women.

Talk to your health care provider if you notice:

Both men and women should call their provider if they have headaches or vision problems.

Maintain normal body weight and healthy eating habits may help in some cases. Other causes may not be preventable.

Ali O, Donohoue PA. Hypofunction of the testes. In: Kliegman RM, Stanton BF, St. Geme JW III, et al., eds. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Elsevier Saunders; 2011:chap 577.

Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society Clinical Practice guideline. J Clin Endocrinol Metab. 2010;95:2536-59. PMID: 20525905 http://www.ncbi.nlm.nih.gov/pubmed/20525905

Kansra AR, Donohoue PA. Hypofunction of the ovaries. In: Kliegman RM, Stanton BF, St. Geme JW III, et al, eds. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Elsevier Saunders; 2011:chap 580.

Swerdloff RS, Wang C. The testis and male sexual function. In: Goldman L, Schafer AI. Goldman's Cecil Medicine. 24th ed. Philadelphia, PA: Elsevier Saunders; 2012:chap 242.

Review Date: 10/25/2014 Reviewed By: Brent Wisse, MD, Associate Professor of Medicine, Division of Metabolism, Endocrinology & Nutrition, University of Washington School of Medicine, Seattle, WA. Also reviewed by David Zieve, MD, MHA, Isla Ogilvie, PhD, and the A.D.A.M. Editorial team.

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Hypogonadism - UT Medical Center

Testosterone levels in men decline with age, at a rate of about 1% per year beginning at about 40 years old.3 Epidemiological studies have determined that total testosterone follows an age-related decline with mean serum concentration at the age of 75 years approximately two thirds that at 25 years.4

According to reports, approximately 74% of chronic opioid users5, 50% of AIDS patients6, 52% of obese men7, 50% of diabetic men7,8 have low testosterone.

Other causes of lowered testosterone levels include: injury, infection, or loss of the testicles; chemotherapyor radiation treatment for cancer; genetic abnormalities such as Klinefelter's Syndrome (extra X chromosome); hemochromatosis(too much iron in the body); dysfunction of the pituitary gland; inflammatory diseases such as sarcoidosis (a condition that causes inflammation of the lungs); chronic illness; chronic kidney failure; liver cirrhosis; stress; and, alcoholism.

3Feldman HA, et al. J. Clin Endocrinol Metab 2002; 87 (2):589-98 4Myers et al. Rev Urol 2003; 5 (4) 216-226 5Daniell HW., J Pain. 2002; 3:377-384 6Dobs AS. Baillires Clin Endocrinol Metab. 1998; 12:379-390 7Mulligan T, et al. Int J Clin Pract. 2006;60:762-769 8Bodie J, et al. J Urol. 2003;169:22622264 9Jackson JA et al., AM. J. Med. Sci. 1992,304 (1) 4-8

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Lipocine - Hypogonadism

Loss of gonadal function of any cause. Diagnosis requires testing of sex hormone and gonadotropin levels. This section includes absent or delayed puberty, primary testicular failure, premature ovarian failure, and secondary hypogonadotropic hypogonadism.

Detailed history,including pubertal development,is mandatory in all patients as this may reduce the list of differential diagnoses considerably.

Specific lines of questioning are indicated according to the exact problem, as below.

The list of differential diagnoses will be different in a patient with multiple medical problems or an obvious congenital condition.

Serious systemic illness of any cause is associated with pubertal delay. Specific conditions associated with abnormal pubertal develoment include the intersex disorders, pseudopseudohypoparathyroidism, Cushing's syndrome andcongenital hypothyroidism.

Pubertal delay is defined by theabsence of thelarche by age 13, or menarche by age 16.

Assess thetiming ofpuberty in as much detail as possible: timing of secondary hair development, breast development and menarche in females, increase in testicular and penile volume, early morning erections and voice breaking in males.

Loss of secondary sexual characteristics such as body hair,and aninability to build new muscle mayoccur withgonadotropin deficiency of any cause.

Weight loss may indicate the development of hypopituitarism or hyperthyroidism. Hypogonadotropic hypogonadism may also occur with Cushing's syndrome and in obesity.

Tall stature and a feminine or 'eunucoid' body shape may be associated with absent puberty in males.

Gynaecomastia may indicate gonadotropin deficiency but in the absence of other symptoms other causes should be considered. Gynaecomastia occurring in conjunction with weight loss should alert to the possibility of malignancy and other systemic diseases.

Absent libido occurs with primary hypogonadism.

New onset loss of libido may be associated with hypogonadism though may be multifactorial.

This may indicate sex hormone deficiency.

Differential diagnoses differ between primary and secondary amenorrhoea.

For secondary amenorrhoea or oligomenorrhoea, specifically assess for symptoms ofpolycystic ovarian syndromeas well as hyperprolactinaemia and thyroid dysfunction below.

Previous pregnancies may help define the duration of disease.

Amenorrhoea and breast swelling are signs of early pregnancy which may not be noticed in the oligomenorrhoeic patient.

Post partum haemorrhage leading to Sheehans syndrome as a cause of hypopituitarism is possible if the patient was unable to breast feed and developed secondary amenorrhoea.

Frequency of shaving varies widely but is usually constant within an individual adult.

Loss of early morning erections is usually important though erectile dysfunction is frequently multifactorial. Symptoms of erectile dysfunction may not be forthcoming unless specifically asked about.

These are all causes of gonadal failure, though orchitis is frequently asymptomatic.

Maldescent may be associated with gonadal dysfunction as well as an increased risk of malignancy.

Hyperprolactinaemia of any cause usually causes hypogonadotropic hypogonadism.

Ask about headache, visual disturbance, breast swelling and galactorrhoea.

Hypothyroidism is a common cause ofdelayed puberty.

Also ask whether the patient hasdeveloped increased sweating, palpitations, tremor, weight loss or diarrhoea, as thyrotoxicosis may also cause gynaecomastia andoligomenorrhoea.

Patients presenting with infertility can on rare occasion befound to havehypopituitarism.

Anorexia nervosa and very low BMI of any cause may cause hypothalamic dysfunction.

Soyacontains large amounts of phytoestrogens which may interfere with the hypothalamic-pituitary-gonadal axis and may be associated with reversible gyncecomastia.

Steroids also interact with the hypothalamic-pituitary-gonadal axis and may occasionally be found in preparations thought by the patient to be 'natural' or 'herbal'.

Excessive exercise may lead to hypothalamic dysfunction.

Various agents associated with hypogonadism are listed below (although it is not exhaustive):

Opiates and recreational drugs, for examplediamorphine, morphine sulphate,heroin, marijuana and alcohol.

Steroids, for examplehydrocortisone, beclamethasone, fluticasone interfere with the hypothalamo-pituitary axis.

Exogenous testosterone,for exampleused forfitness, body building or other sports, will alsoenhance estrogen synthesis.

Estrogens and drugs with estrogen-like activity, such as diethylstilbestrol anddigoxin will also cause gynaecomastia in some cases.

Phenytoin alsoenhances estrogen synthesis, as dogonadotropins.

A range of drugs can inhibit testosterone synthesis or action, includingketoconazole, metronidazole, alkylating agents,spironolactone, cimetidine, flutamide, finasteride, and etomidate.

Other agentssuch asmethyldopa,tricyclic antidepressants, diazepam, penicillamine, omeprazole, phenothiazines, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors have all been reported as causing gynaecomastia, though themechanisms underlying this are unclear.

Patients may not report anosmia unless specifically questioned. Kallmanns syndrome is typified by anosmia and hypogonadotropic hypogonadism.

Dental aplasia, cleft palate and dental malalignment requiring orthodontic treatment may not be obvious and are associated with Kallmanns syndrome.

Congenital abnormalities of the urogenital system may occur with Kallmanns and Turners syndromes.

Specifically ask if any family members, for example cousins,have had late or absent puberty,infertility or simply never had children.

Ask also if any family members have had dental or palatal problems, kidney abnormalities or anosmia which might suggest a family history of Kallmanns syndrome.

Congenital hypothyroidism is associated with delayed puberty.

Hypothyroidismis also associated with Turner's syndrome.

These may be associated with Turner's syndrome.

Deafness may be associated with Turner's syndrome.

Patients with Klinefelter's syndrome have an increased incidence of psychiatric problems.

Multiple congenital conditions includeabnormalities of sexual development. Examples includepseudopseudohypoparathyroidism, Russell Silver syndrome, congenital hypothyroidism.

Specificdisorders of sexual development may also be encountered: congenital adrenal hyperplasia,androgen insensitivity syndrome, 5-alpha reductase deficiency, aromatase deficiency, gonadal dysgenesis, Kallmann's syndrome, Turner's syndrome, Klinefelter's syndrome, and other rarer conditions.

Loss of acuity or failing vision at night are worrying features suggesting optic nerve involvement.

Visual field loss, for examplehomonymous hemianopia,is common indicating chiasmal impingement.

It is worth specifically asking whether patients drive and, if so, whether they have had trouble noticing street signs on either side of the road as this may be the first instance in which field loss is noticed.

Assess for red flag symptoms: headaches present on waking, whichworsen on coughing or leaning forward, are more suggestive of increased intracranial pressure.

Headaches or lancing pain across one section of the head or face only are more suggestive of cranial nerve involvement particularly with disease in the cavernous sinus.

Vague symptoms of tiredness, nausea and dizziness may indicate the development of hypopituitarism with ACTH or TSH deficiency.

Diabetes insipidusis uncommon with intrinsic pituitary disease and suggests para sellar pathology.

Pituitary metastases are common and may be the first presentation of malignant disease.

Ask specifically about change of bowel habit, new prostatic symptoms andbreast lumps.

Ask the patient whetherthere has been a change in their weight or body shape. New bruising, redness, acne, hirsuitism, oligomenorrhoea, diabetes, hypertension, depression, osteoporosisor muscle weakness are all associated with Cushing's syndrome, which leads to pubertal delay and hypogonadotropic hypogonadism.

A detailed history of gynaecomastia will help elucidate likely causes.

Peripubertal breast swelling is common and usually requires no treatment. Long standing obesity may be associated with bilateral non-glandular breast swelling. Sudden onset and unilateral gynaecomastia should alert to the possibility of breast cancer.

Sudden onset and unilateral gynaecomastia should alert to the possibility of breast cancer.

Changes in the skin, nipple or unilateral discharge is highly suspicious for breast cancer.

Bilateral galactorrhoea is suggestive of elevated prolatin.

Weight loss and malaise occur with hypopituitarism but may indicate malignancy.

Hyperthyroidism may be associated with gynaecomastia: ask about sweating, palpitations, tremor, weight loss ordiarrhoea.

Hypothyroidism may be associated with delayed puberty.

Cirrhosis, haemachromatosis and congestive cardiac failure are frequently associated with gynaecomastia.

Various agents associated with hypogonadism are listed below (although it is not exhaustive):

Opiates and recreational drugs, for examplediamorphine, morphine sulphate,heroin, marijuana and alcohol.

Steroids, for examplehydrocortisone, beclamethasone, fluticasone interfere with the hypothalamo-pituitary axis.

Exogenous testosterone,for exampleused forfitness, body building or other sports -will alsoenhance estrogen synthesis.

Estrogens and drugs with estrogen-like activity, such as diethylstilbestrol anddigoxin will also cause gynaecomastia in some cases.

Phenytoin alsoenhances estrogen synthesis, as dogonadotropins.

A range of drugs can inhibit testosterone synthesis or action, includingketoconazole, metronidazole, alkylating agents,spironolactone, cimetidine, flutamide, finasteride, and etomidate.

Other agentssuch asmethyldopa,tricyclic antidepressants, diazepam, penicillamine, omeprazole, phenothiazines, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors have all been reported as causing gynaecomastia, though themechanisms underlying this are unclear.

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Hypogonadism diagnosis - history - Endobible

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Hypogonadism - Risks, Symptoms and Leading Causes | Treato

Male hypogonadism is a deficiency of testosterone in men. About 5 percent to 6 percent of men experience male hypogonadism, and the condition becomes more common as a man ages.

Hypogonadism may be congenital or may be acquired as the result of aging, disease, drugs or other factors. Symptoms include low sperm count, decreased libido, erectile dysfunction, fatigue, sleep disturbances and depression.

In primary hypogonadism, the testes fail to make testosterone because of infection or injury to the testes. Common causes of testicular dysfunction include cancer treatment, excessive alcohol consumption, Klinefelter syndrome, mumps orchitis and autoimmune disorders.

In secondary hypogonadism, which is more common, the hypothalamus or the pituitary gland fails to produce enough hormones. These hormones are needed to trigger the testes to produce testosterone. Secondary hypogonadism can be caused by Kallmann syndrome, pituitary or hypothalamic tumors or disorders, obesity, diabetes and Prader-Willi syndrome.

Following a complete medical history and physical, tests will be done to measure the man's testosterone level. Because testosterone levels naturally fall off during the day, a testosterone blood test is done between 7:00 am and 10:00 am.

If the test shows a low testosterone level, additional tests may be ordered to check for a pituitary gland disorder. A blood test to check serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and prolactin levels can help determine the cause. If needed, specialized testing may be performed in the Endocrine Diagnostic Unit, based at Froedtert Hospital.

Other tests may be used to measure sperm count, check for testicle or gland tumors, or identify a genetic (congenital) cause.

For men with primary hypogonadism, treatment typically involves lifelong testosterone replacement therapy. Options for replacement therapy include:

Too much testosterone can place a man at a higher risk for blood clots. As with any hormonal therapy, its important to monitor patients as treatment progresses. Men receiving hormone replacement therapy are seen for blood tests and a prostate exam at one, three and six months after beginning treatment. They continue to be seen every six months.

Secondary hypogonadism is treated by addressing the root cause - a disorder with the hypothalamus or pituitary gland.

Treatment may also be needed for conditions related to hypogonadism, including:

Infertility related to secondary hypogonadism may respond to hormonal replacement therapy. Infertility related to primary hypogonadism, however, does not respond to hormonal therapy. In these cases, a man and his partner can be referred to the Reproductive Medicine Center for help conceiving a child.

Link:
Testosterone Deficiency, Hypogonadism | Froedtert Hospital ...

Early symptoms of low testosterone in men include low libido (sex drive). As levels become very low, sexual dysfunction (also called "erectile dysfunction (ED)" or "impotence") often develops. Other signs and symptoms of low testosterone may include depression, fatigue, osteoporosis, loss of muscle mass, an increase in abdominal fat, development of breast tissue (gynecomastia) and infertility.

Symptoms of low testosterone in women may include low libido (sex drive), sexual dysfunction, fatigue, loss of muscle mass, an increase in body fat and bone loss.

Pituitary Symptoms

There are many causes of low testosterone. These can be differentiated with hormone testing. Pituitary dysfunction is one cause of low testosterone and can result from compression of the pituitary gland by a large pituitary tumor. In addition, excess hormone secretion by a pituitary tumor can cause low testosterone either directly or indirectly. For example, elevated prolactin, cortisol or GH levels can cause low testosterone. Testosterone levels normalize with treatment of the tumor in some, but not all, cases. There are other causes of low testosterone that are not related to pituitary tumors. These include anabolic steroid use (for body building or athletic enhancement), obesity, depression, and testicular failure.

Research Studies

The complications of low testosterone in men include infertility, sexual dysfunction, osteoporosis, loss of muscle mass, depression and fatigue.

Research Studies

You're likely to start by seeing your family doctor or a general practitioner. However, in some cases when you call to set up an appointment, you may be referred immediately to an endocrinologist, a doctor who specializes in endocrine (hormonal) disorders.

Special Instructions (If available, please bring):

Our clinic assistants will help you update your hospital registration and insurance information.

Thank you.

Appointments

Testosterone levels can be measured directly. An endocrinologist can test for causes of low testosterone, including elevated prolactin levels. Sometimes other blood tests are indicated to make the diagnosis or determine the cause, including free testosterone, sex hormone binding globulin, leutinizing hormone (LH) or evaluation for Cushing's disease or acromegaly.

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If the underlying cause of the low testosterone can be determined and corrected, testosterone levels often rise to normal levels. Medical treatment to lower prolactin levels from a prolactinoma often results in normalization of testosterone level. In addition, resection of large nonfunctioning pituitary tumors that are causing low testosteorne by compressing the pituitary gland results in restoration of normal testosterone levels in approximately 50% of cases. Cure of acromegaly or Cushing's disease also often results in normalization of testosterone levels. In patients for whom the cause cannot be determined or addressed, testosterone replacement therapy can be prescribed by an endocrinologist with expertise in this area. There are a number of different preparations available, including gels, creams, patches, and injections. Your endocrinologist can discuss the pros and cons of the different options with you. S/he will also check lab results to make sure it is safe to prescribe the medication and that your testosterone levels on the medication are appropriate. If bone density does not improve when testosterone has been normalized, additional medications may be necessary.

There are no FDA-approved testosterone preparations for women, who make 10 to 20 times less testosterone than men and therefore need much lower replacement doses than men.

Appointments

Research is ongoing in the Neuroendocrine Unit on the effects of low testosterone and testosterone treatment in both men and women.

Research Studies

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Hypogonadism and Hypogonadism Resources - What is ...

Morbidity for men and women with hypogonadism includes infertility and an increased risk of osteoporosis; there is no increase in mortality.

Hypogonadotropic hypogonadism (see the image below) is one of several types of hypogonadism.

History

Considerations in the evaluation of males with hypogonadism include the following:

For postpubertal males, the rate of beard growth, libido and sexual function, muscle strength, and energy levels

Possible causes of acquired testicular failure (eg, mumps orchitis, trauma, radiation exposure of the head or testes, and chemotherapy)

Drugs that may interrupt testicular function: Including agents that interfere with testosterone synthesis, such as spironolactone, cyproterone, marijuana, heroin, and methadone

Considerations in the evaluation of females with hypogonadism include the following:

Signs associated with Turner syndrome (eg, lymphedema, cardiac or renal congenital anomalies, and short growth pattern)

Age of menarche

Physical examination

Considerations in the physical examination of males with hypogonadism include the following:

Evaluation of the testes: This is the most important feature of the physical examination; determine whether both testes are palpable, their position in the scrotum, and their consistency; testes size can be quantitated by comparison with testicular models (orchidometer), or their length and width may be measured

Examination of the genitalia for hypospadias

Examination of the scrotum to see if it is completely fused

Evaluation of the extent of virilization

Staging of puberty: Use the Tanner criteria for genitalia, pubic hair, and axillary hair

Examination for signs of Klinefelter syndrome (eg, tall stature, especially if the legs are disproportionately long, gynecomastia, small or soft testes, and a eunuchoid body habitus)

Considerations in the physical examination of females with hypogonadism include the following:

Examination of the genitalia is important

Determination of the extent of androgenization: May be adrenal or ovarian in origin and is demonstrated in pubic and axillary hair

Determination of the extent of estrogenization: As evidenced by breast development and maturation of the vaginal mucosa

Examination for signs of Turner syndrome (eg, short stature, webbing of the neck [such as pterygium colli], a highly arched palate, short fourth metacarpals, widely spaced nipples, or multiple pigmented nevi)

See Clinical Presentation for more detail.

The following studies may be indicated in males with hypogonadism:

Follicle-stimulating hormone (FSH) levels

Luteinizing hormone (LH) levels

Prolactin levels

Testosterone levels

Thyroid function

Seminal fluid examination

Karyotyping

Testicular biopsy

For males after puberty, the Guidelines of the Endocrine Society[2] require that the diagnosis of hypogonadism be based on symptoms and signs of hypogonadism plus the presence of a low testosterone level measured on at least 2 occasions.

The following studies may be indicated in females with hypogonadism:

Additional tests in the evaluation of patients with hypogonadism include the following:

Adrenocorticotropic hormone (ACTH) stimulation testing: In patients in whom a form of congenital adrenal hyperplasia is suspected, adrenal steroid synthesis is best evaluated by performing a cosyntropin (ACTH 1-24) stimulation test

Luteinizing-hormone releasing hormone (LHRH) stimulation testing: To distinguish between true hypogonadotropic hypogonadism and constitutional delay in growth and maturation

Testicular tissue testing: If the testes are not palpable and if it is not certain whether any testicular tissue is present, administering human chorionic gonadotropin (hCG) and measuring testosterone response may be helpful

See Workup for more detail.

Hormonal replacement

The simplest and most successful treatment for males and females with either hypergonadotropic or hypogonadotropic hypogonadism is replacement of sex steroids, but the therapy does not confer fertility or, in men, stimulate testicular growth.

When fertility is desired, an alternative therapy for men with hypogonadotropic hypogonadism is administration of pulsatile LHRH or injections of hCG and FSH. (In patients with hypergonadotropic hypogonadism, fertility is not possible.)

In a 6-year European study of men being treated for hypogonadism, long-term transdermal testosterone treatment did not increase prostate-specific antigen (PSA) levels or influence prostate cancer risk.[3, 4]

Investigators used data from a 5-year, open-label extension of a 1-year trial of a transdermal testosterone patch (Testopatch) in men with hypogonadism. Study subjects wore two 60 cm2 patches, each of which delivered 2.4 mg of testosterone per day. More than 90% of patients had PSA concentrations below 2 ng/mL during the 6-year study, and no prostate cancer was found in patients over the course of the trial.

See Treatment and Medication for more detail.

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Hypogonadism - Medscape Reference