Archive for the ‘Hypogonadism’ Category

Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010; 95(6): 2536-59. PubMed

Choosing Wisely. An initiative of the ABIM Foundation. [Accessed: Sep 2017]

Dean JD, McMahon CG, Guay AT, Morgentaler A, Althof SE, Becher EF, Bivalacqua TJ, Burnett AL, Buvat J, Meliegy AE, Hellstrom WJ, Jannini EA, Maggi M, McCullough A, Torres LO, Zitzmann M. The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men. J Sex Med. 2015; 12(8): 1660-86. PubMed

Dohle G, Arver S, Bettocchi C, et al. Guidelines on male hypogonadism. European Association of Urology. Arnhem (the Netherlands) [Accessed: Jun 2017]

Kushnir MM, Blamires T, Rockwood AL, Roberts WL, Yue B, Erdogan E, Bunker AM, Meikle W. Liquid chromatography-tandem mass spectrometry assay for androstenedione, dehydroepiandrosterone, and testosterone with pediatric and adult reference intervals. Clin Chem. 2010; 56(7): 1138-47. PubMed

Morales A, Bebb RA, Manjoo P, Assimakopoulos P, Axler J, Collier C, Elliott S, Goldenberg L, Gottesman I, Grober ED, Guyatt GH, Holmes DT, Lee JC, Canadian Mens Health Foundation Multidisciplinary Guidelines Task Force on Testosterone Deficiency. Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline. CMAJ. 2015; 187(18): 1369-77. PubMed

Paduch DA, Brannigan RE, Fuchs EF, Kim ED, Marmar JL, Sandlow JI. The laboratory diagnosis of testosterone deficiency. Urology. 2014; 83(5): 980-8. PubMed

Seftel AD, Kathrins M, Niederberger C. Critical Update of the 2010 Endocrine Society Clinical Practice Guidelines for Male Hypogonadism: A Systematic Analysis. Mayo Clin Proc. 2015; 90(8): 1104-15. PubMed

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Hypogonadism, Male | ARUPConsult Lab Test Selection

Hypogonadism is the underproduction of sex hormones by the gonads, or sex organs. Male hypogonadism refers to the underproduction of testosterone, which can severely limit a growing boys sexual development and frustrate an adult males quality of life.

The easiest way to understand the effects of hypogonadism is to understand the effects of proper testosterone levels in a mans development. The male sex hormone contributes to everything from the deepening of the voice, the growth of body hair, and muscle building to sex drive and general self confidence. A lack of testosterone has the opposite effect, and can contribute to a higher-pitched voice, loss of body hair, muscle loss, lowered sex drive, and decreased confidence.

Hypogonadism can occur as early as fetal development, which may lead to androgyny, but male hypogonadism in particular can also occur as a result of testicular injury. Hypogonadism sustained before puberty is particularly problematic, as it will greatly affect puberty. Low testosterone during puberty can lead to:

Hypogonadism that occurs after puberty is less obvious, but can also lead to major problems, such as:

While these are some of the physical symptoms of hypogonadism, it is worth noting that hypogonadism, no matter when it occurs, can also lead to persistent psychological and emotional duress. Common stressors that accompany male hypogonadism may include:

Areas Low Testosterone Can Affect

Many adult males who have gone through puberty normally but experience hypogonadism in later life may not recognize its symptoms. If you suspect that you may be suffering from hypogonadism, testosterone replacement therapy is a potential treatment option. The pervasive symptoms of hypogonadism are caused in large part by low testosterone, and testosterone replacement therapy can greatly improve quality of life and sex drive.

Dr. Olivieri has many decades of experience treating men with low testosterone, and has helped thousands of men experience the benefits of normal testosterone levels, improving their lives, marriages, and mobility. If you know someone who may be suffering from hypogonadism or low testosterone in general, consider calling Aegonics Medical for a consultation.

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Hypogonadism Testosterone Therapy Treatment | Ageonics Medical

What Is Hypogonadism?

Hypogonadism occurs when your sex glands produce little or no sex hormones. The sex glands, also calledgonads, are primarily the testes in men and the ovaries in women. Sex hormones help control secondary sex characteristics, such as breast development in women, testicular development in men, and pubic hair growth. Sex hormones also play a role in the menstrual cycle and sperm production.

Hypogonadism may also be known asgonad deficiency. It may be calledlow serum testosteroneorandropause when it happens in males.

Most cases of this disorder respond well to appropriate medical treatment.

9 Warning Signs of Low Testosterone

Types

There two types of hypogonadism are primary and central hypogonadism.

Primary hypogonadism means that you dont have enough sex hormones in your body due to a problem in your gonads. Your gonads are still receiving the message to produce hormones from your brain, but they arent able to produce them.

In central hypogonadism, the problem lies in your brain. The hypothalamus and pituitary gland in your brain, which control your gonads, arent working properly.

Causes

The causes of primary hypogonadism include:

Central, or secondary, hypogonadism may be due to:

Symptoms

Symptoms that may affect females include:

Symptoms that may affect males include:

Diagnosis

Your doctor will conduct a physical exam to confirm that your sexual development is at the proper level for your age. They may examine your muscle mass, body hair, and your sexual organs.

If your doctor thinks you might have hypogonadism, the first round of testing will involve checking your sex hormone levels. Youll need a blood test to check your level of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Your pituitary gland makes these reproductive hormones.

Youll have your estrogen level tested if youre female. Youll have your testosterone level tested if youre male. These tests are usually drawn in the morning, which is when your hormone levels are highest. If youre male, your doctor may also order a semen analysis to check your sperm count. Hypogonadism can reduce your sperm count.

Your doctor may order more blood tests to help confirm the diagnosis of hypogonadism and rule out any underlying causes.

Iron levels can affect your sex hormones. For this reason, your doctor may test for anemia, or iron deficiency. Your doctor may also wish to measure your prolactin levels. Prolactin is a hormone that promotes breast development and breast milk production in women, but its present in both genders. Your doctor may also check your thyroid hormone levels because thyroid problems can cause symptoms similar to hypogonadism.

Imaging tests can also be useful in diagnosis. Anultrasoundof the ovaries uses sound waves to create an image of the ovaries and check for any problems, including ovarian cysts and polycystic ovarian syndrome (PCOS).Your doctor may order MRIscans or CTscans to check for tumors in your pituitary gland.

Treatments

Your treatment will involve increasing the amount of female sex hormones in your body if youre a woman.

Your first line of treatment will probably be estrogen therapy if youve had a hysterectomy. Either a patch or pill can administer the supplemental estrogen hormone.

Because increased estrogen levels can increase your risk of endometrial cancer, youll be given a combination of estrogen and progesterone if women who havent had a hysterectomy. Progesterone can lower your risk of endometrial cancer if youre taking estrogen.

Other treatments can target specific symptoms. If youre a woman and you have a decreased sex drive, you may receive low doses of testosterone. If you have menstrual irregularities or trouble conceiving, you may receive injections of the hormone human choriogonadotropin (hCG) or pills containing FSH to trigger ovulation.

Testosterone is a male sex hormone. Testosterone replacement therapy (TRT) is a widely used treatment for hypogonadism in males. You can get testosterone replacement therapy by:

Injections of a gonadotropin-releasing hormone may trigger puberty or increase your sperm production.

Treatment for males and females is similar if the hypogonadism is due to a tumor on the pituitary gland. Treatment may include radiation, medication, or surgery to shrink or remove the tumor.

Outlook

According to the Urology Care Foundation, hypogonadism is a chronic condition that requires lifelong treatment. Your sex hormone level will probably decrease if you stop treatment.

Seeking support through therapy or support groups can help you before, during, and after treatment.

Can Testosterone Supplements Improve Your Sex Drive?

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Hypogonadism: Types, Causes, & Symptoms - healthline.com

Male Hypogonadism DrugMarketreport provides key statistics on the market status of the Male Hypogonadism DrugManufacturers and is a valuable source of guidance and direction for companies and individuals interested in the Male Hypogonadism DrugIndustry. The Male Hypogonadism Drugindustry report firstly announced the Male Hypogonadism DrugMarket fundamentals: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on.

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Table of Contents:

Chapter 1 Overview of Male Hypogonadism DrugMarket1.1 Brief Overview of Male Hypogonadism DrugIndustry1.2 Development of Male Hypogonadism DrugMarket1.3 Status of Male Hypogonadism DrugMarket

Chapter 2 Manufacturing Technology of Male Hypogonadism DrugIndustry2.1 Development of Male Hypogonadism DrugManufacturing Technology2.2 Analysis of Male Hypogonadism DrugManufacturing Technology2.3 Trends of Male Hypogonadism DrugManufacturing Technology

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Chapter 4 Global and Chinese Male Hypogonadism DrugMarket4.1 2012-2017 Global Capacity, Production and Production Value of Male Hypogonadism DrugMarket4.2 2012-2017 Global Cost and Profit of Male Hypogonadism DrugMarket4.3 Male Hypogonadism DrugMarket Comparison of Global and Chinese Male Hypogonadism DrugIndustry4.4 2012-2017 Global and Chinese Supply and Consumption of Male Hypogonadism DrugMarket4.5 2012-2017 Chinese Import and Export of Male Hypogonadism Drug

Chapter 5 Market Status of Male Hypogonadism DrugIndustry5.1 Male Hypogonadism DrugMarket Competition of Industry by Company5.2 Market Competition of Industry by Country (USA, EU, Japan, Chinese etc.)5.3 Male Hypogonadism DrugMarket Analysis of Consumption by Application/TypeContinue

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Male Hypogonadism Drug Market Analysis, Share and Size, Trends, Industry Growth And Segment Forecasts To 2021 - satPRnews (press release)

MarketResearchNest.com adds Asia-Pacific Male Hypogonadism Market Report 2017new report to its research database. The report spread across 113 pages with multiple tables and figures in it.

This report studies the Asia-Pacific Male Hypogonadism market status and outlook of global and major regions, from angles of manufacturers, regions, product types and end industries; this report analyzes the top manufacturers in global and major regions, and splits the Asia-Pacific Male Hypogonadism market by product type and applications/end industries.

The global Asia-Pacific Male Hypogonadism market is valued at XX million USD in 2016 and is expected to reach XX million USD by the end of 2022, growing at a CAGR of XX% between 2016 and 2022.

Browse full table of contents and data tables at

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Major players in the market are identified through secondary research and their market revenues determined through primary and secondary research. The major players in Asia-Pacific Male Hypogonadism market include

Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, IBSA Institut Biochimque.

Geographically, this report is segmented into several key Regions, with production, consumption, revenue, market share and growth rate of Asia-Pacific Male Hypogonadism in these regions, from 2012 to 2022 (forecast), covering

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Asia-Pacific Male Hypogonadism Market (K Units) and Revenue (Million USD) Market Split by Regions

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On the basis of product, the Asia-Pacific Male Hypogonadism market is primarily split intoTestosterone Replacement Therapy, Gonadotropin-Releasing Hormones Therapy.

Asia-Pacific Male Hypogonadism Market (K Units) and Revenue (Million USD) Market Split by Product Type

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate of Asia-Pacific Male Hypogonadism for each application, including:

Kallmann Syndrome, Klinefelters Syndrome, Pituitary Disorders, Others.

Asia-Pacific Male Hypogonadism Market (K Units) and Revenue (Million USD) Market Split by end users

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or other factors are not accounted for in the market forecast.

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Asia-Pacific Male Hypogonadism Market by Region, Production, Consumption, Revenue, Market Share and Growth ... - satPRnews (press release)

Treatment for adults

Treatment for male hypogonadism depends on the cause and whether you're concerned about fertility.

Hormone replacement. For hypogonadism caused by testicular failure, doctors use male hormone replacement therapy (testosterone replacement therapy, or TRT). TRT can restore muscle strength and prevent bone loss. In addition, men receiving TRT may experience an increase in energy, sex drive, erectile function and sense of well-being.

If a pituitary problem is the cause, pituitary hormones may stimulate sperm production and restore fertility. Testosterone replacement therapy can be used if fertility isn't an issue. A pituitary tumor may require surgical removal, medication, radiation or the replacement of other hormones.

In boys, testosterone replacement therapy (TRT) can stimulate puberty and the development of secondary sex characteristics, such as increased muscle mass, beard and pubic hair growth, and growth of the penis. Pituitary hormones may be used to stimulate testicle growth. An initial low dose of testosterone with gradual increases may help to avoid adverse effects and more closely mimic the slow increase in testosterone that occurs during puberty.

Several testosterone delivery methods exist. Choosing a specific therapy depends on your preference of a particular delivery system, the side effects and the cost. Methods include:

Injection. Testosterone injections (testosterone cypionate, testosterone enanthate) are safe and effective. Injections are given in a muscle. Your symptoms might fluctuate between doses depending on the frequency of injections.

You or a family member can learn to give TRT injections at home. If you're uncomfortable giving yourself injections, a nurse or doctor can give the injections.

Testosterone undecanoate (Aveed), an injection recently approved by the Food and Drug Administration, is injected less frequently but must be administered by a health care provider and can have serious side effects.

Gel. There are several gel preparations available with different ways of applying them. Depending on the brand, you either rub testosterone gel into your skin on your upper arm or shoulder (AndroGel, Testim, Vogelxo), apply with an applicator under each armpit (Axiron) or pump on your front and inner thigh (Fortesta).

As the gel dries, your body absorbs testosterone through your skin. Gel application of testosterone replacement therapy appears to cause fewer skin reactions than patches do. Don't shower or bathe for several hours after a gel application, to be sure it gets absorbed.

A potential side effect of the gel is the possibility of transferring the medication to another person. Avoid skin-to-skin contact until the gel is completely dry or cover the area after an application.

Oral testosterone isn't recommended for long-term hormone replacement because it might cause liver problems.

Testosterone therapy carries various risks, including contributing to sleep apnea, stimulating noncancerous growth of the prostate, enlarging breasts, limiting sperm production, stimulating growth of existing prostate cancer and blood clots forming in the veins. Recent research also suggests testosterone therapy might increase your risk of a heart attack.

Sept. 29, 2016

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Male hypogonadism - Treatment - Mayo Clinic

Nagpur: For the first time in the city, four patients have undergone treatment for infertility for male hypogonadism. They were put through a therapy conceptualized by endocrinologist Dr Pramod Gandhi following which three of their wives conceived.

On Sunday, Gandhi delivered a talk on 'Male hypogonadism' during a medical conference on 'core endocrinology' which was organized by the Nagpur Diabetes and Endocrine Centre in collaboration with Diabetic Association of India (DAI) and Association of Medical Faculties (AMF) at a city hotel.

Male hypogonadism, a problem not often discussed at such forums, is a condition in which the body doesn't produce enough testosterone. It can occur at any age fetal development, before puberty or during adulthood. Signs and symptoms depend on when the condition develops.

Infertility, erectile dysfunction, obesity, loss of strength, decreased beard and body hair growth, decreased sex drive and weakening of bone are the common symptoms.

"Until now, the city couldn't do much if the patient is suffering from infertility because of hypogonadism," Gandhi told TOI.

Gandhi combined two injections combined human chorionic gonadotrophin (HCG) and human menopausal gonadotrophin (HMG) to treat the four patients. "Until now both of these injections were being used on women for some other purpose," he said.

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Wives of 3 of 4 patients treated for hypogonadism conceive - Times of India

Report provides a complete understanding of the pipeline activities covering all clinical, pre-clinical and discovery stage products.

This press release was orginally distributed by SBWire

Albany, NY -- (SBWIRE) -- 08/16/2017 -- The topic of Hypogonadism can be an embarrassing subject for an affected male. Nevertheless, it's important that any man battling the symptoms of Hypogonadism to get over his embarrassment and be taken care of by a medical professional. A new pipeline study, related to the therapeutics activities for male hypogonadism has been recently broadcasted to the wide repository of Market Research Hub (MRH), with the title of "Male Hypogonadism-Pipeline Insight, 2017". The study highlights the pharmacological action of various therapeutics and their history of research and development activities.

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Male hypogonadism is defined as the failure of the testes to produce androgen, sperm or both. Although the disorder is extremely common, its exact prevalence is uncertain. It is a condition in which the body doesn't produce enough testosterone, the hormone that plays a key role in masculine growth and development during puberty. It may adversely affect multiple organ functions and quality of life. Signs and symptoms depend on when the condition develops. The research analyses its symptoms, which include fatigue, hot flashes, infertility, decrease in muscle mass and loss of bone mass (osteoporosis). When hormone levels decline, men can easily experience significant psychological and physical changes.

Moreover, this study provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The coverage of pipeline products based on the numerous stages of development ranging from early development to approved or issued stage. In this subsequent section, details of foremost pipeline products which includes, product description, licensing and collaboration details and other developmental activities are also mentioned. This study has been built using proprietary databases along with latest updates and featured news & press releases from various university sites and industry-specific third party sources.

Looking to the therapeutics overview, the research studies that the levels of testosterone in men start to fall after the age of 40. It has been estimated that 8.4% of men aged 5079 years have testosterone deficiency. Some types of male hypogonadism can be treated with testosterone replacement therapy. 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.

Browse Full Report with TOC - http://www.marketresearchhub.com/report/male-hypogonadism-pipeline-insight-2017-report.html

For a competitive analysis, the research has listed key companies operating in the market, focusing on their research and development efforts, adoption to changing trends and their efforts to discover new therapeutics for male hypogonadism. Also, the report covers dormant and discontinued pipeline projects related to the Male Hypogonadism. With this information, the new entrants in the market can modify the therapeutic portfolio by identifying inactive projects and understanding the factors that might have halted their progress.

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About Market Research HubMarket Research Hub (MRH) is a next-generation reseller of research reports and analysis. MRH's expansive collection of market research reports has been carefully curated to help key personnel and decision makers across industry verticals to clearly visualize their operating environment and take strategic steps.

MRH functions as an integrated platform for the following products and services: Objective and sound market forecasts, qualitative and quantitative analysis, incisive insight into defining industry trends, and market share estimates. Our reputation lies in delivering value and world-class capabilities to our clients.

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For more information on this press release visit: http://www.sbwire.com/press-releases/pipeline-landscape-of-male-hypogonadism-covering-therapeutic-assessment-and-drug-portfolio-in-2017-848559.htm

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Pipeline Landscape of Male Hypogonadism Covering Therapeutic Assessment and Drug Portfolio in 2017 - Digital Journal

A new study shows a significant improvement in both sexual and urinary function as well as quality of life for hypogonadal men who undergo long-term testosterone replacement therapy.

These findings appear in the Journal of Urology.

Testosterone is a steroid hormone involved in the regulation of sexual function, urinary health and metabolism as well as a number of other critical functions. For most men, testosterone concentration declines slowly with age and may not cause immediate major symptoms. However, some men may experience a host of signs and sumptoms constituting a clinical condition called Testosterone Deficiency (TD), or male hypogonadism, which is attributed to insufficient levels of testosterone. As a result, they experience symptoms as varied as erectile dysfunction, low energy, fatique, depressed mood and an increased risk of diabetes.

Researchers from the Boston University School of Medicine (BUSM) and Public Health (BUSPH) collaborated with a group of urologists in Germany to investigate the effects of long-term testosterone replacement therapy on urinary health and sexual function as well as quality of life in men with diagnosed, symptomatic testosterone deficiency. More than 650 men in their 50s and 60s enrolled in the study, some with unexplained testosterone deficiency and others with known genetic and auto-immune causes for their hypogonadism.

"It is thought that testosterone treatment in men may increase prostate size and worsen lower urinary tract symptoms," said Abdulmaged Traish, PhD, professor of urology at BUSM.

However, he and Gheorghe Doros, PhD, professor of biostatistics at BUSPH, discovered that despite increased prostate size in the group that received testosterone therapy, there were fewer urinary symptoms such as frequent urination, incomplete bladder emptying, weak urinary stream and waking up at night to urinate.

In addition to these subjective improvements, the researchers conducted objective testing that showed that those men treated with testosterone emptied their bladders more fully. Finally, testosterone treatment also increased the scores patients received on assessments of their erectile/sexual health and general quality of life.

The findings of this study are of great significance to men suffering with symptomatic testosterone deficiency. Traish emphasized the value of this treatment option, stating that, "[Testosterone therapy] is well-tolerated with progressive and sustained improvement in urinary and sexual function and overall improvement in quality of life."

Explore further: Testosterone undecanoate improves sexual function in men with type 2 diabetes

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Long-term testosterone therapy improves urinary, sexual function and quality of life - Medical Xpress

Global Male Hypogonadism Sales Market Research Report 2017 to 2022 provides a unique tool for evaluating the market, highlighting opportunities, and supporting strategic and tactical decision-making. This report recognizes that in this rapidly-evolving and competitive environment, up-to-date marketing information is essential to monitor performance and make critical decisions for growth and profitability. It provides information on trends and developments, and focuses on markets and materials, capacities and technologies, and on the changing structure of the Male Hypogonadism Sales Market.

Companies Mentioned are Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, IBSA Institut Biochimque.

The Global Male Hypogonadism Sales market consists of different international, regional, and local vendors. The market competition is foreseen to grow higher with the rise in technological innovation and M&A activities in the future. Moreover, many local and regional vendors are offering specific application products for varied end-users. The new vendor entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology.

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Global Male Hypogonadism Sales (K Units) and Revenue (Million USD) Market Split by Product Type

Global Male Hypogonadism Sales (K Units) by Application (2016-2022)

(2016-2022)

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Chapter 13, 14 and 15, to describe Male Hypogonadism Sales sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Male Hypogonadism Sales Market Research Report 2017 to 2022 - The Donohue Report

US specialty pharma firm Lipocine (Nasdaq: LPCN) has resubmitted a New Drug Application (NDA) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Initial market reaction saw a 5.9% gain to $4.49 for the stock, but it closed Friday up just 0.7% at $4.7.

Lipocine had previously submitted an NDA for LPCN 1021 and received a Complete Response Letter (CRL) from the US Food and Drug Administration in June 2016. The CRL identified a deficiency related to the dosing algorithm for the proposed label.With the goal of addressing this deficiency, the company successfully completed a dosing validation (DV) study, which confirmed the validity of a fixed dose approach without the need for dose titration to orally administer LPCN 1021. The efficacy results of the DV study, as well as an integrated safety set (ISS) from all previously-conducted clinical trials, including 52-week safety results from the Phase III Study of Androgen Replacement (SOAR) clinical study, form the basis for the NDA resubmission.

"Resubmission of this NDA as planned is an important milestone in bringing LPCN 1021 to patients," said Dr Mahesh Patel, chairman, president and chief executive of Lipocine. "We believe the results from the recently completed DV study address the label-related deficiency identified by the FDA in the CRL. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men. We anticipate a six-month review by the FDA with a projected PDUFA date in the first quarter of 2018 assuming the FDA acknowledges our submission is a complete response," he noted.

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Lipocine resubmits NDA for LPCN 1021 in hypogonadism - The Pharma Letter (registration)

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you uncover the news from the biotech and pharmaceutical industries.

So let's get started!

Though it currently holds the first-line therapy spot in kidney cancer, Pfizer's (NYSE:PFE) multi-targeted kinase inhibitor sunitinib is in danger of losing this hegemony as effective agents like cabozantinib from Exelixis (NASDAQ:EXEL) and Bristol-Myers Squibb's (NYSE:BMY) nivolumab are explored in first-line metastatic disease.

PFE's response? Go low. As in earlier treatment stages. The company has previously announced a supplemental drug application for sunitinib in adjuvant therapy for patients with kidney cancer and high risk of recurrence. This would be the first approved targeted therapy in an earlier treatment setting.

Now, we have gotten word that PFE has a meeting with the Oncology Drug Advisory Committee (ODAC) on September 19 to discuss this application. The ODAC will be responsible for scientific grilling of the company on the risks and benefits of sunitinib in this earlier treatment line. It will also be responsible for giving the scientific thumbs up or thumbs down, a crucial step in the FDA's overall review process.

Looking forward: I'm sure PFE has its fingers crossed, as first-line metastatic therapy is beset by competition from promising agents. Moving to even earlier treatment settings could allow it to remain in the foreground of clinicians' minds when managing patients at high risk for recurrence. But it's no sure thing, either, as we'll find out once the FDA publishes the advisory brief a few days before the actual meeting. So keep your eyes peeled for that news in about a month!

Lipocine, Inc. (NASDAQ:LPCN) is a developmental pharma company engaged in the development of therapies for low testosterone, formally called hypogonadism. In particular, its late-stage candidate is an oral version of testosterone, which the company hopes will address challenges associated with injectable and topical forms of the hormone.

However, the company was hit with a complete response letter from the FDA back in June of last year, which detailed some issues with the titration scheme proposed for marketing. This led to difficulty translating how the drug would be used in the real world compared with how it was used in the phase 3 study.

The next step for LPCN was to conduct a dosing validation study to prove that the proposed algorithm will yield the expected results seen in the phase 3 study. Now, over a year later, the company has resubmitted its NDA to the FDA.

Looking forward: Because the complete response letter in June 2016 did not outline any other major issues divulged by LPCN, it would be surprising if the FDA comes back with more negative feedback. Of course, it's possible that the dosing validation study will not be sufficient, but I imagine that the company has done its homework with FDA meetings to try and nail down exactly what it needs. And that can serve as a lesson for all of us in the investment community: small issues can lead to pretty long-term delays.

You might expect that most of the big news to come out of the world of hormone receptor-positive breast cancer is related to the CDK4/6 inhibitors marketed by Lilly (NYSE:LLY), Novartis (NYSE:NVS), and Pfizer. But of course research continues along a huge number of other avenues.

One of those is the targeting of a member of the EGFR family, HER3. And this specifically is where Merrimack Pharmaceuticals (NASDAQ:MACK) finds itself. Its investigational monoclonal antibody, seribantumab, is designed to block HER3 dimer formation with other members of the EGFR family.

This is potentially important due to the known role of PI3K/Akt signaling in hormone-positive breast cancer. And HER3 is the most potent activator of this signaling pathway in the EGFR family. Seribantumab in combination with exemestane was shown to reduce the risk of death in patients with hormone receptor-positive breast cancer and progression on endocrine therapy at last year's AACR meeting.

Now, the company is moving forward with a phase 2 randomized study assessing the potential benefit of this antibody combined with fulvestrant in untreated, advanced breast cancer.

Looking forward: Seribantumab has yielded some interesting early findings in breast cancer, though its history has been a bit mixed. A prior study in ovarian cancer showed that this agent did not improve outcomes for patients when given in combination with paclitaxel. However, hormone receptor-positive breast cancer has a known association with PI3K/Akt signaling, so if the findings here are discrepant, I won't be shocked.

As always, thank you for tuning into a new edition of this digest. If you found it helpful, I hope you will consider becoming a follower of mine on Seeking Alpha, as this will allow you to receive real-time email updates when new articles of mine go live!

Have a great day!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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3 Things In Biotech You Should Learn Today: August 12, 2017 - Seeking Alpha

Global Male Hypogonadism Market Research Report provides insights of Male Hypogonadism industry over past 5 years and a forecast until 2022.Report studies the Male Hypogonadism Market status and future trend in global market, splits Male Hypogonadism by type and by applications, to fully and deeply research and reveal the market situation and future forecast.

Male Hypogonadism Market report would come in handy to understand your competitors and give you an insight about sales; volumes, revenues in the Male Hypogonadism industry, assists in making strategic decisions. It reduces the risks involved in making decisions as well as strategies for companies and individuals interested in the Male Hypogonadism industry. Both established and new players in Male Hypogonadism industry can use report to understand the market.

Male Hypogonadism Market: Type wise segment:

Male Hypogonadism Market: Applications wise segment:

Get a Sample PDF of Male Hypogonadism Market Research report @ http://www.360marketupdates.com/enquiry/request-sample/10971895

Type wise and application wise consumption figures are given. With the help of supply and consumption data, gap between these two is also explained.

Male Hypogonadism Market report contains proven analysis by regions, especially for North America, Europe, China, Japan, Southeast Asia and India, focusing top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering top players like Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, IBSA Institut Biochimque, and many more.

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Male Hypogonadism Market Growth Forecast Analysis by ... - Green Mountain Outlook

Worldwide Male Hypogonadism Market 2017 presents a widespread and fundamental study of Male Hypogonadism industry along with the analysis of subjective aspects which will provide key business insights to the readers. Global Male Hypogonadism Market 2017 research report offers the analytical view of the industry by studying different factors like Male Hypogonadism market growth, consumption volume, market trends and Male Hypogonadism industry cost structures during the forecast period from 2017 to 2022.

Male Hypogonadism market studies the competitive landscape view of the industry. The Male Hypogonadism report also includes development plans and policies along with manufacturing processes. The major regions involved in Male Hypogonadism Market are (United States, EU, China, and Japan).

For Sample Copy Of The Report Click Here: https://market.biz/report/global-male-hypogonadism-market-2017/127538/#inquiry

Leading Manufacturers Analysis in Global Male Hypogonadism Market 2017:

1 Astrazeneca Plc.2 Merck & Co. Inc.3 Laboratories Genevrier4 Allergan Plc.5 Endo International Plc.6 Ferring7 AbbVie Inc.8 Eli Lilly and Company Ltd.9 Finox Biotech10 Teva Pharmaceutical Industries Ltd.11 Bayer AG12 IBSA Institut Biochimque

Male Hypogonadism Market: Type Segment Analysis

Testosterone Replacement TherapyGonadotropin-Releasing Hormones Therapy

Male Hypogonadism Market: Applications Segment Analysis

Kallmann SyndromeKlinefelters SyndromePituitary DisordersOthers

The Male Hypogonadism report does the thorough study of the key industry players to understand their business strategies, annual revenue, company profile and their contribution to the global Male Hypogonadism market share. Diverse factors of the Male Hypogonadism industry like the supply chain scenario, industry standards, import/export details are also mentioned in Global Male Hypogonadism Market 2017 report.

Key Highlights of the Male Hypogonadism Market:

A Clear understanding of the Male Hypogonadism market based on growth, constraints, opportunities, feasibility study.

Concise Male Hypogonadism Market study based on major geographical regions.

Analysis of evolving market segments as well as a complete study of existing Male Hypogonadism market segments.

Discover More About Report Here: https://market.biz/report/global-male-hypogonadism-market-2017/127538/

Furthermore, distinct aspects of Male Hypogonadism market like the technological development, economic factors, opportunities and threats to the growth of Male Hypogonadism market are covered in depth in this report. The performance of Male Hypogonadism market during 2017 to 2022 is being forecasted in this report.

In conclusion, Global Male Hypogonadism market 2017 report presents the descriptive analysis of the parent market based on elite players, present, past and futuristic data which will serve as a profitable guide for all the Male Hypogonadism industry competitors.

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Global Male Hypogonadism Market 2017 Allergan Plc., Endo International Plc., Ferring, AbbVie Inc. - DailyCommerceNews

Lipocine Inc. (NASDAQ:LPCN) just announced the resubmission of a New Drug Application (NDA) for a drug called LPCN 1021. The company is trading a touch down on the news but theres a good chance that the majority of its impact will hit during the session on Thursday, given the timing of the update hitting press.

The drug is one of three primary development programs that Lipocine is running concurrently (although its reasonable to suggest that its the lead of the three, given the recent development) and its targeting a condition associated with a deficiency of endogenous testosterone, also known as hypogonadism. The term hypogonadism, when used in general, means diminished functional activity of the gonadsthe testes in males or the ovaries in femalesthat may result in diminished sex hormone biosynthesis. In this instance specifically, Lipocine is using the drug to target the condition in men. One way to think of this condition (and to use a term thats often used to explain the condition to patients and families outside of the medical space) is interrupted puberty. The standard functions of puberty hair growth, sperm production, physical growth, that sort of thing dont happen. Right now, the standard of care (SOC) treatment involves hormone replacement therapy (testosterone replacement therapy, or TRT) and this TRT type therapy can restore muscle strength and prevent bone loss. It has its drawbacks, however, with these primarily rooted in administration frequency and dosing volume. Patients have to visit outpatient setting regularly or have to inject the testosterone themselves, which can be painful and potentially unsafe as well as can potentially causemisdosing.

This is where Lipocine and LPCN 1021 comes into play.

The drug is whats called a prodrug, which means it doesnt become active until after administration. Once its in the body, the drug is metabolized naturally and converts into a pharmacologically active medication. This can reduce dose necessity, improve administration frequency and perhaps most importantly means the drug can be taken as an oral administration as opposed to an injection.

So thats the science and the logic behind this program. What does the latest update mean for the company and its shareholders?

The program has had a pretty rough time over the last twelve months or so. Data from the phase III that underpinned an initially submitted NDA looked strong, with the drug hitting against its primary endpoint of restoring normal testosterone levels in men on a twice daily dosing schedule. When the company got a response back from the agency, however, it wasnt great. The response came in the form of a Complete Response Letter (CRL) back in June last year, through which the agency identified a deficiency related to the dosing algorithm for the proposed label and concurrently requested (well, not outright requested, as thats not how it works, but implied that it would be necessary) whats called a dosing validation (DV) study to overcome the issue.

Lipocine got right to it, completed the DV study (to a level that it deemed) successfully and as per the latest release resubmitted the application to the agency this month.

So whats next?

Well, now its all about whether the DV study data actually resolves the issue that the FDA brought up or not. These sorts of issues arent generally overly demanding to resolve and we expect that the resubmission should glide through to acceptance (not approval, acceptance) based on the data that Lipocine has submitted. Beyond that, the question becomes whether the phase III data has shown that the drug can be safe and as importantly effective in bringing testosterone levels in men with hypogonadism to normal (or near normal) levels.

Again, we cant put forward anything but a speculative opinion on this one but, with that said, speculative doesnt need to be uneducated. In this instance, and given the wealth of data supportive of safety and efficacy that hasnt just been collected by Lipocine for this program but that is already in place as relates to the prodrug technology that underpins the drug in question, we think theres a good chance of a green light.

PDUFA (if the drug is accepted for review) should come at some point during February 2018.

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Here's What Lipocine Inc. (NASDAQ:LPCN)'s Latest Announcement Means For Shareholders - Market Exclusive

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Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced the resubmission of a New Drug Application (NDA) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Lipocine had previously submitted an NDA for LPCN 1021 and received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in June 2016. The CRL identified a deficiency related to the dosing algorithm for the proposed label. With the goal of addressing this deficiency, the company successfully completed a dosing validation (DV) study, which confirmed the validity of a fixed dose approach without the need for dose titration to orally administer LPCN 1021. The efficacy results of the DV study, as well as an integrated safety set (ISS) from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement (SOAR) clinical study, form the basis for the NDA resubmission.

Resubmission of this NDA as planned is an important milestone in bringing LPCN 1021 to patients, said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. We believe the results from the recently completed DV study address the label-related deficiency identified by the FDA in the CRL. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men. We anticipate a six-month review by the FDA with a projected PDUFA date in the first quarter of 2018 assuming the FDA acknowledges our submission is a complete response.

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Lipocine (LPCN) Resubmits NDA for Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism - StreetInsider.com

Worldwide Male Hypogonadism Market 2017 presents a widespread and fundamental study of Male Hypogonadism industry along with the analysis of subjective aspects which will provide key business insights to the readers. Global Male Hypogonadism Market 2017 research report offers the analytical view of the industry by studying different factors like Male Hypogonadism market growth, consumption volume, market trends and Male Hypogonadism industry cost structures during the forecast period from 2017 to 2022.

Male Hypogonadism market studies the competitive landscape view of the industry. The Male Hypogonadism report also includes development plans and policies along with manufacturing processes. The major regions involved in Male Hypogonadism Market are (United States, EU, China, and Japan).

For Sample Copy Of The Report Click Here: http://qyresearch.us/report/global-male-hypogonadism-market-2017/53475/#inquiry

Leading Manufacturers Analysis in Global Male Hypogonadism Market 2017:

1 Astrazeneca Plc.2 Merck & Co. Inc.3 Laboratories Genevrier4 Allergan Plc.5 Endo International Plc.6 Ferring7 AbbVie Inc.8 Eli Lilly and Company Ltd.9 Finox Biotech10 Teva Pharmaceutical Industries Ltd.11 Bayer AG12 IBSA Institut Biochimque

Male Hypogonadism Market: Type Segment Analysis

Testosterone Replacement TherapyGonadotropin-Releasing Hormones Therapy

Male Hypogonadism Market: Applications Segment Analysis

Kallmann SyndromeKlinefelters SyndromePituitary DisordersOthers

The Male Hypogonadism report does the thorough study of the key industry players to understand their business strategies, annual revenue, company profile and their contribution to the global Male Hypogonadism market share. Diverse factors of the Male Hypogonadism industry like the supply chain scenario, industry standards, import/export details are also mentioned in Global Male Hypogonadism Market 2017 report.

Key Highlights of the Male Hypogonadism Market:

A Clear understanding of the Male Hypogonadism market based on growth, constraints, opportunities, feasibility study.

Concise Male Hypogonadism Market study based on major geographical regions.

Analysis of evolving market segments as well as a complete study of existing Male Hypogonadism market segments.

Discover More About Report Here: http://qyresearch.us/report/global-male-hypogonadism-market-2017/53475/

Furthermore, distinct aspects of Male Hypogonadism market like the technological development, economic factors, opportunities and threats to the growth of Male Hypogonadism market are covered in depth in this report. The performance of Male Hypogonadism market during 2017 to 2022 is being forecasted in this report.

In conclusion, Global Male Hypogonadism market 2017 report presents the descriptive analysis of the parent market based on elite players, present, past and futuristic data which will serve as a profitable guide for all the Male Hypogonadism industry competitors.

Read the original here:
Global Male Hypogonadism Market 2017- Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc. - DailyCommerceNews

Global Male Hypogonadism Market Research Report 2017 to 2022presents an in-depth assessment of the Male Hypogonadism including enabling technologies, key trends, market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents forecasts for Male Hypogonadism investments from 2017 till 2022.

This study answers several questions for stakeholders, primarily which market segments they should focus upon during the next five years to prioritize their efforts and investments. The Male Hypogonadism markets are highly fragmented due to the presence of numerous small and large vendors. Most of the international pharmaceutical companies are facing challenges such as price pressure, regulatory constraints, and competition from local and other international pharmaceutical companies in the Male Hypogonadism markets. The competitive environment in the market is expected to intensify with an increase in product extensions, technological innovations, and increase in mergers and acquisitions.

These stakeholders include Male Hypogonadism manufacturers such as : Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, IBSA Institut Biochimque.

Inquire for sample of report @:

https://www.marketinsightsreports.com/reports/080413335/global-male-hypogonadism-market-research-report-2017/inquiry

Primary sources are mainly industry experts from core and related industries, and suppliers, manufacturers, distributors, service providers, and organizations related to all segments of the industrys supply chain. The bottom-up approach was used to estimate the global market size of Male Hypogonadism based on end-use industry and region, in terms of value. With the data triangulation procedure and validation of data through primary interviews, the exact values of the overall parent market, and individual market sizes were determined and confirmed in this study.

Secondly the study, besides estimating the Male Hypogonadism market potential till 2022, analyzes on who can be the market leaders and what partnerships would help them to capture the market share. The report gives an overview about the dynamics of the market, by discussing various aspects such as drivers, restraints, Porters 5 forces, value chain, customer acceptance and investment scenario.

TheGlobal Male Hypogonadism marketconsists of different international, regional, and local vendors. The market competition is foreseen to grow higher with the rise in technological innovation and M&A activities in the future. Moreover, many local and regional vendors are offering specific application products for varied end-users. The new vendor entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology.

The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications.

Global Male Hypogonadism Sales (K Units) and Revenue (Million USD) Market Split by Product Type:

Global Male Hypogonadism Sales (K Units) by Application (2016-2022)

by Application

(2016-2022)

The research provides answers to the following key questions:

This independent 112 page report guarantees you will remain better informed than your competition. With over 150 tables and figures examining the Male Hypogonadism market, the report gives you a visual, one-stop breakdown of the leading products, submarkets and market leaders market revenue forecasts as well as analysis to 2022.

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Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Storage Area Network Switch in these regions, from 2012 to 2022 (forecast), covering

by Regions

The report provides a basic overview of the Male Hypogonadism industry including definitions, classifications, applications and industry chain structure. And development policies and plans are discussed as well as manufacturing processes and cost structures.

Then, the report focuses on global major leading industry players with information such as company profiles, product picture and specifications, sales, market share and contact information. Whats more, the Male Hypogonadism industry development trends and marketing channels are analyzed.

The report segments this market based on products, portability, methods, applications, and end users. Among various end users, the hospitals segment is expected to account for the largest share of the market and is expected to grow at the highest CAGR from 2014 to 2019. The high growth in this segment can be attributed to the rising rate of maternal mortality and fetal birth defects, and increasing number of initiatives taken by government organizations for improving prenatal care.

The research includes historic data from 2012 to 2016 and forecasts until 2022 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs. The report will make detailed analysis mainly on above questions and in-depth research on the development environment, market size, development trend, operation situation and future development trend of Male Hypogonadism on the basis of stating current situation of the industry in 2017 so as to make comprehensive organization and judgment on the competition situation and development trend of Male Hypogonadism Market and assist manufacturers and investment organization to better grasp the development course of Male Hypogonadism Market.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

There are 15 Chapters to deeply display the global Male Hypogonadism market.

Chapter 1, to describe Male Hypogonadism Introduction, product scope, market overview, market opportunities, market risk, market driving force;

Chapter 2, to analyze the top manufacturers of Grain and Seed Cleaning Equipment, with sales, revenue, and price of Grain and Seed Cleaning Equipment, in 2016 and 2017;

Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2016 and 2017;

Chapter 4, to show the global market by regions, with sales, revenue and market share of Grain and Seed Cleaning Equipment, for each region, from 2012 to 2017;

Chapter 5, 6, 7,8and 9, to analyze the key regions, with sales, revenue and market share by key countries in these regions;

Chapter 10and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2012 to 2017;

Chapter 12, Male Hypogonadism market forecast, by regions, type and application, with sales and revenue, from 2017 to 2022;

Chapter 13, 14 and 15, to describe Male Hypogonadism sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Male Hypogonadism Market Research Report 2017 To 2022 - Equity Insider (press release)

Male Hypogonadism Market Predicted Double-Digit Growth Rate by 2024

This press release was orginally distributed by SBWire

Sarasota, FL -- (SBWIRE) -- 08/01/2017 -- Global Male Hypogonadism Market: Overview

Male hypogonadism is a medical condition, wherein the testes fail to generate enough testosterone which leads to incomplete development or delayed puberty. The condition is related to the development of breast tissues, impaired development of muscle mass, lack of deepening of the voice, and impaired body hair growth.

Request Free Sample Report @ https://www.zionmarketresearch.com/sample/male-hypogonadism-market

Global Male Hypogonadism Market: Segmentation

The male hypogonadism market is globally segmented into therapy, drug delivery, and type. On the basis of therapy, the market is segregated into testosterone replacement therapy and gonadotropin-releasing hormones therapy. The gonadotropin-releasing hormones therapy is further sub-divided into luteinizing hormone (LH), human chorionic gonadotropin (hCG), follicle-stimulating hormone (FSH), and gonadotropin-releasing hormone (GnRH). Based on the drug delivery, the market is categorized into injectables, topical gels, transdermal patches, and others. Depending on the type, the market is divided into Kallmann syndrome, Klinefelters syndrome, pituitary disorders, and others.

Global Male Hypogonadism Market: Growth Factors

The key factor that is driving the male hypogonadism market includes increasing cases of testosterone deficiency among men, increasing awareness among people about hypogonadism treatment owing to awareness drives that are organized by several governments across the world, and increasing infertility rates. The high risk of hypogonadism among the aged population with obesity and diabetes and escalating cases of chronic disorders among the geriatrics are further boosting the market's growth. On the other hand, factors such as high side effects of testosterone products challenge the growth of the market. The market players are focusing on research and development activities to introduce newer products with less or negligible side effects and better results. Technological advancements are anticipated to extend new opportunities to the market's growth.

Request Report TOC (Table of Contents) @ https://www.zionmarketresearch.com/toc/male-hypogonadism-market

Global Male Hypogonadism Market: Regional Analysis

The male hypogonadism market can be segmented into regions such as North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa. North America dominates the market owing to the increase in the number of individuals that are suffering from the primary and secondary conditions of hypogonadism, and the rising awareness among the people about treatment. Other factors that contribute to this growth are the presence of unconventional health care infrastructure and growing popularity of the technologically advanced products which will offer new opportunities to the top market players in this market. The region is strongly followed by Europe. Asia-Pacific region is expected to offer productive opportunities to this market owing to the modernization of the healthcare infrastructure in the developing economies of India and China and the growing awareness about the treatment for the condition. In Asia Pacific, there is a rise in the number of people that suffer from hypogonadism and infertility rates coupled with the rise in the geriatric population base having obesity and diabetes are triggering the growth of the market.

Global Male Hypogonadism Market: Competitive Players

Some of the key market players that are involved in the male hypogonadism market include Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, and IBSA Institut Biochimque.

Browse detail report @ https://www.zionmarketresearch.com/report/male-hypogonadism-market

Global Male Hypogonadism Market by Geographical Analysis: North America( U.S.), Europe( UK, France, Germany), Asia-Pacific (China, Japan, India), Latin America( Brazil), Middle East and Africa

Our value reports provide full, in-depth analysis of the parent market including most significant changes in market dynamics; the report also presents the detailed overview on segmentation of this market. We managed to present as many important pieces of information in essential form thanks to our report You will learn more about former, on-going, and projected market analysis in terms of volume and value, assessment of niche industry developments and Market share analysis. We have not forgotten to present key strategies for major players, emerging segments and regional markets and last but not least, testimonials to companies in order to fortify their foothold in the market.

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About Zion Market ResearchZion Market Research is an obligate company. We create futuristically, cutting edge, informative reports ranging from industry reports, a company reports to country reports. We provide our clients not only with market statistics unveiled by avowed private publishers and public organizations but also with Vogue and newest industry reports along with pre-eminent and niche company profiles. Our database of market research reports comprises a wide variety of reports from Cardinal Industries. Our database is been updated constantly in order to fulfill our clients with prompt and direct online access to our database. Keeping in mind the client's needs, we have included expert insights on global industries, products, and market trends in this database. Last but not the least, we make it our duty to ensure the success of clients connected to usafter allif you do well, a little of the light shines on us.

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Male Hypogonadism Market Set for Expansive Growth over Next 10 Years - Digital Journal

SummaryMale Hypogonadism - Pipeline Review, H1 2017The latest Pharmaceutical and Healthcare disease pipeline guide Male Hypogonadism - Pipeline Review, H1 2017, provides an overview of the Male Hypogonadism (Male Health) pipeline landscape.

Male hypogonadism is a condition in which the body doesn't produce enough testosterone. Symptoms include fatigue, hot flashes, infertility, decrease in muscle mass and loss of bone mass (osteoporosis). Risk factors for hypogonadism include HIV/AIDS, Klinefelter syndrome, Kallmann syndrome, injury to testicles and untreated sleep apnea.

Report Highlights

The Pharmaceutical and Healthcare latest pipeline guide Male Hypogonadism - Pipeline Review, H1 2017, provides comprehensive information on the therapeutics under development for Male Hypogonadism (Male Health), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Male Hypogonadism (Male Health) pipeline guide also reviews of key players involved in therapeutic development for Male Hypogonadism and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/Withdrawn, Phase III, Phase II, Phase I, IND/CTA Filed and Preclinical stages are 3, 1, 4, 7, 2, 1 and 5 respectively. Similarly, the Universities portfolio in Phase II stages comprises 1 molecules, respectively.

Male Hypogonadism (Male Health) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from The proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

Scope

- The pipeline guide provides a snapshot of the global therapeutic landscape of Male Hypogonadism (Male Health).- The pipeline guide reviews pipeline therapeutics for Male Hypogonadism (Male Health) by companies and universities/research institutes based on information derived from company and industry-specific sources. - The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages.- The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities.- The pipeline guide reviews key companies involved in Male Hypogonadism (Male Health) therapeutics and enlists all their major and minor projects.- The pipeline guide evaluates Male Hypogonadism (Male Health) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type.- The pipeline guide encapsulates all the dormant and discontinued pipeline projects. - The pipeline guide reviews latest news related to pipeline therapeutics for Male Hypogonadism (Male Health)

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Reasons to access

- Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies.- Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.- Find and recognize significant and varied types of therapeutics under development for Male Hypogonadism (Male Health).- Classify potential new clients or partners in the target demographic.- Develop tactical initiatives by understanding the focus areas of leading companies.- Plan mergers and acquisitions meritoriously by identifying key players and its most promising pipeline therapeutics.- Formulate corrective measures for pipeline projects by understanding Male Hypogonadism (Male Health) pipeline depth and focus of Indication therapeutics.- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and Scope.- Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline.

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Table of ContentsList of TablesList of FiguresIntroductionGlobal Markets Direct Report CoverageMale Hypogonadism - OverviewMale Hypogonadism - Therapeutics DevelopmentPipeline OverviewPipeline by CompaniesPipeline by Universities/InstitutesProducts under Development by CompaniesProducts under Development by Universities/InstitutesMale Hypogonadism - Therapeutics AssessmentAssessment by TargetAssessment by Mechanism of ActionAssessment by Route of AdministrationAssessment by Molecule TypeMale Hypogonadism - Companies Involved in Therapeutics DevelopmentAntares Pharma IncClarus Therapeutics IncEndoCeutics IncFerring International Center SAIASO BioMed IncLipocine IncM et P Pharma AGMedlab Clinical LtdMerck & Co IncMereo Biopharma Group PlcPantarhei Bioscience BVRepros Therapeutics IncTakeda Pharmaceutical Company LtdTesoRx Pharma LLCViramal LtdMale Hypogonadism - Drug ProfilesBGS-649 - Drug ProfileProduct DescriptionMechanism Of ActionR&D Progresscorifollitropin alfa - Drug ProfileProduct DescriptionMechanism Of ActionR&D Progressenclomiphene citrate - Drug ProfileProduct DescriptionMechanism Of ActionR&D ProgressIAS-167A - Drug ProfileProduct DescriptionMechanism Of ActionR&D ProgressKisspeptin-10 - Drug ProfileProduct DescriptionMechanism Of ActionR&D Progressleuprolide acetate - Drug ProfileProduct DescriptionMechanism Of ActionR&D ProgressLibidua - Drug ProfileProduct Description.. Continued

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Research details developments in the male hypogonadism - market ... - WhaTech

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Male Hypogonadism - Pipeline Review, H1 2017" report to their offering.

The latest Pharmaceutical and Healthcare latest pipeline guide Male Hypogonadism - Pipeline Review, H1 2017, provides comprehensive information on the therapeutics under development for Male Hypogonadism (Male Health), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

The Male Hypogonadism (Male Health) pipeline guide also reviews of key players involved in therapeutic development for Male Hypogonadism and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/Withdrawn, Phase III, Phase II, Phase I, IND/CTA Filed and Preclinical stages are 3, 1, 4, 7, 2, 1 and 5 respectively. Similarly, the Universities portfolio in Phase II stages comprises 1 molecules, respectively.

Male Hypogonadism (Male Health) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/research/gxm3xp/male_hypogonadism

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Male Hypogonadism Pipeline Report, H1 2017 - Therapeutics Review of 15 Companies & Drug Profiles - Research ... - Business Wire (press release)

The man presented with a lack of facial hair and a five centimetre penis

SOME men will go to great lengths to add inches to their manhood.

From penis pumps to pills and lotions, there are many products on the market that claim to add length and girth to a mans member.

Getty Images

But a recent study from Pakistan suggests one method actually works hormone injections.

A 34-year-old man went to an endocrine (hormonal) clinic complaining of a lack of facial and pubic hair.

Further examination found his pituitary gland responsible for secreting hormones into the body was functioning as normal but he had a lack of testosterone in his body.

Testosterone is the male sex hormone and plays a key role in the development of the testicles and secondary sexual characteristics like body hair.

The patients lack of testosterone caused his lack of facial and pubic hair as well as decreased early morning erections and delayed ejaculation, doctors noted.

His penis measured just five centimetres long, according to the case study published in the BMJ.

The patient was prescribed testosterone injections and after nine months his penis length grewto the average size of a man his age around 7-10 centimetres.

The mans testosterone levels remained at a normal level after he finished the course of treatment and he was advised to stop the injections.

The patient presented to the clinic with a condition known ashypogonadism a condition where the male body does not produce enough testosterone.

Men suffering hypogonadism may also have an impaired ability to produce sperm, according to the Mayo Clinic.

Patients may be born with the condition but in some cases it can develop later in life.

Symptoms of the condition depend on when hypogonadism developed.

If the body doesnt produce enough testosterone during foetal development then a man may have impaired growth of his penis and testicles.

A child who is genetically male but has the condition may be born with; female genitals, ambiguous genitals or underdeveloped male genitals.

If the conditions strikes during puberty it can cause; decreased muscle mass, lack of body hair, lack of a deep voice, smaller penis and testes and development of breast tissue.

If it strikes during adulthood it can cause erectile dysfunction, infertility, decreases in beard and body hair growth and the development of breast tissue.

Getty Images

Hypogonadism can be caused by a problem with the testicles, which produces testosterone, or a problem with the pituitary gland, which signals to the testes to produce testosterone.

Treatment usually involves hormone replacement to make up for the lack of testosterone.

This can come in injections, patches, gums, gels and nasal sprays.

But the treatment isnt without risks.

It can contribute to sleep apnea, stimulated growth of the prostate, enlarged breasts, limited sperm production, blood clots and heart attack.

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Man, 34, 'DOUBLES the size of his penis in nine months thanks to hormone injections' - The Sun

You may have heard stories that men will go to crazy lengths to addinches onto their penis, but a recent case study from Pakistan showsone method that actually worked. The 34-year-old patientdid not produce enough testosterone due to a pre-existing condition.However, after testosterone injections over the course of ninemonths, the mans penis nearly doubled in length.

According to the case study published in the BMJ Case Reports, the man was diagnosed with hypogonadism, a condition where his body does not produce enough testosterone. The man had originally gone todoctorswith concerns about his lack of facial and body hair, but closer examination revealed a significant problem with his penis and testicle size. As a result of his condition, he never fully developed, was unable to grow a beard or armpit and pubic hair, had very few erections, and an extremely small penis1.9 inches when stretched. In addition, he also had very small testicles, about half the size of the average mans.

Read: Do You Have The Right Amount Of Testosterone In Your Body? Normal Range Of Male Sex Hormone Revealed In Landmark Study

The patient was given hormone injections over a period of nine months, andhis penis length nearly doubledto 3.7 inches. His testicles also doubled in size, IFLscience reported.

This is very much a case of do not try this at home, IFL Science emphasized. The mans case was rare and the same treatment would likely not help lengthen the penis of an otherwise healthy male.

According to The Mayo Clinic, male hypogonadism can begin during fetal development, before puberty, or even during adulthood. In the case of adult hypogonadism, the condition can cause erectile dysfunction, infertility, decrease in beard and body hair growth, decrease in muscle mass, development of breast tissue, and loss of bone mass. The condition can also cause mental and emotional changes similar to those women may experience during menopause. These may include fatigue, decreased sex drive, difficulty concentrating, and hot flashes, The Mayo Clinic reported.

Hypogonadism is marked by inadequate testosterone production, but this can either be caused by a problem with the testicles, or a problem with the pituitary gland. The condition can also lead tomore serious complications than just a small penis, such asambiguous or abnormal genitalia, and unproportional growth of the arms and legs when compared to the rest of the body.

Hypogonadism is usually treated with some type of hormone replacement therapy to make up for the lack of testosterone, whether this be an injection, patch, gel, gum, tablet, or nasal spray. However, this treatment also carries a number of risks, such as prostate growth, enlarging of breasts, problems with sperm production, and the formation of blood clots.

See Also:

7 Ways To Naturally Boost Testosterone Levels In Men, From Alcohol Intake To Sleep Routines

Testosterone May Protect Against Allergic Asthma In Men: Male Sex Hormone Holds Key To Asthma Treatments

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Man Doubles Penis Size After Testosterone Injections To Treat Hypogonadism Condition - Medical Daily

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Zion Market Research, the market research group announced the analysis report titledMale Hypogonadism Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecasts 20162024

Global Male Hypogonadism Market: Overview

Male hypogonadism is a medical condition, wherein the testes fail to generate enough testosterone which leads to incomplete development or delayed puberty. The condition is related to the development of breast tissues, impaired development of muscle mass, lack of deepening of the voice, and impaired body hair growth.

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Global Male Hypogonadism Market: Segmentation

The male hypogonadism market is globally segmented into therapy, drug delivery, and type. On the basis of therapy, the market is segregated into testosterone replacement therapy and gonadotropin-releasing hormones therapy. The gonadotropin-releasing hormones therapy is further sub-divided into luteinizing hormone (LH), human chorionic gonadotropin (hCG), follicle-stimulating hormone (FSH), and gonadotropin-releasing hormone (GnRH). Based on the drug delivery, the market is categorized into injectables, topical gels, transdermal patches, and others. Depending on the type, the market is divided into Kallmann syndrome, Klinefelters syndrome, pituitary disorders, and others.

Global Male Hypogonadism Market: Growth Factors

The key factor that is driving the male hypogonadism market includes increasing cases of testosterone deficiency among men, increasing awareness among people about hypogonadism treatment owing to awareness drives that are organized by several governments across the world, and increasing infertility rates. The high risk of hypogonadism among the aged population with obesity and diabetes and escalating cases of chronic disorders among the geriatrics are further boosting the markets growth. On the other hand, factors such as high side effects of testosterone products challenge the growth of the market. The market players are focusing on research and development activities to introduce newer products with less or negligible side effects and better results. Technological advancements are anticipated to extend new opportunities to the markets growth.

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Global Male Hypogonadism Market: Regional Analysis

The male hypogonadism market can be segmented into regions such as North America, Asia-Pacific, Europe, Latin America, and the Middle East and Africa. North America dominates the market owing to the increase in the number of individuals that are suffering from the primary and secondary conditions of hypogonadism, and the rising awareness among the people about treatment. Other factors that contribute to this growth are the presence of unconventional health care infrastructure and growing popularity of the technologically advanced products which will offer new opportunities to the top market players in this market. The region is strongly followed by Europe. Asia-Pacific region is expected to offer productive opportunities to this market owing to the modernization of the healthcare infrastructure in the developing economies of India and China and the growing awareness about the treatment for the condition. In Asia Pacific, there is a rise in the number of people that suffer from hypogonadism and infertility rates coupled with the rise in the geriatric population base having obesity and diabetes are triggering the growth of the market.

Global Male Hypogonadism Market: Competitive Players

Some of the key market players that are involved in the male hypogonadism market include Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, and IBSA Institut Biochimque.

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Global Male Hypogonadism Marketby Geographical Analysis:North America( U.S.), Europe( UK,France,Germany), Asia-Pacific(China,Japan,India), Latin America( Brazil), Middle East and Africa

Our value reports provide full, in-depth analysis of the parent market including most significant changes in market dynamics; the report also presents the detailed overview on segmentation of this market. We managed to present as many important pieces of information in essential form thanks to our report You will learn more about former, on-going, and projected market analysis in terms of volume and value, assessment of niche industry developments and Market share analysis. We have not forgotten to present key strategies for major players, emerging segments and regional markets and last but not least, testimonials to companies in order to fortify their foothold in the market.

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Male Hypogonadism Market predicts rise in demand by 2016-2024 - People Today 24

Lipocine Inc (NASDAQ:LPCN) is considerably higher in mid-afternoon trading today, currently up 27 cents at $4.29 a boost of nearly seven percent. After the market close yesterday, the company released positive data from a dosing validation as well as a dosing flexibility study evaluating its testosterone replacement therapy (TRT).

The news has also sent Lipocines volume up today, as more than 7.4 million shares of the biotech have changed hands already. On a typical day, only about 164,000 shares of Lipocine end up getting traded.

The companys TRT, called LPCN 1021, was developed for adult males suffering from symptoms associated with a deficiency of endogenous testosterone a conditioned referred to as hypogonadism. According to Lipocines press release yesterday, the dosing validation and flexibility trials confirmed a fixed dose approach moving forward. Additionally, researchers will not need to do dose titration to orally administer the drug.

LPCN 1021 managed to successfully meet the FDAs regulations in the dosing validation study, as 81 percent of the enrolled patients hit average testosterone levels that fall within the normal range. In the dosing flexibility study, 70 percent of the trials subjects had average testosterone levels restored confirming a twice-per-day dosing regime for resubmission moving forward.

We are pleased with the confirmation of LPCN 1021 efficacy, especially with a more practical patient and physician preferred no titration dosing regimen, said the companys Chairman, President, and Chief Executive Officer, Dr. Mahesh Patel. We believe the results should address the label-related deficiency cited by the FDA in our NDA submission.

Dr. Patel told shareholders that he hopes that LPCN 1021 can be a differentiated TRT option for hypogonadism patients that will both improve patient compliance and reduce risk of testosterone interference. The company plans on resubmitting their New Drug Application (NDA) in the third quarter of the current year.

The author of this article holds no position in any of the companies mentioned above.

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Lipocine (LPCN) Spikes On Testosterone Dosing Data - Economic Calendar