Archive for the ‘Hypogonadism’ Category

Denver Business Journal

AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Entry into a Material Definitive Agreement Market Exclusive Aytu BioScience, Inc. is a commercial-stage healthcare company focused on acquiring, developing and commercializing products in the field of urology. The Company focuses on hypogonadism, prostate cancer, urinary tract infections and male infertility. Aytu BioScience Announces the Acquisition of Nuelle, Inc., Developer and Marketer of Fiera Female Personal Care ...PR Newswire (press release) all 3 news articles »

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AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU) Files An 8-K Entry into a Material Definitive Agreement - Market Exclusive

Neurology Advisor

In Hypogonadism, Stroke May Be Prevented With Testosterone Replacement Therapy Neurology Advisor Patients with primary hypogonadism, secondary hypogonadism related to overt hypothalamic pituitary pathology, HIV infection, metastatic cancer, a history of prostate cancer, prostate specific antigen >4 ng/mL, elevated hematocrit, or a history of ...

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In Hypogonadism, Stroke May Be Prevented With Testosterone Replacement Therapy - Neurology Advisor

Endocrinology Advisor

Testosterone Replacement Therapy May Protect Against Stroke, Heart Attack in Hypogonadism Endocrinology Advisor Patients with primary hypogonadism, secondary hypogonadism related to overt hypothalamic pituitary pathology, HIV infection, metastatic cancer, a history of prostate cancer, prostate specific antigen >4 ng/mL, elevated hematocrit, or a history of ...

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Testosterone Replacement Therapy May Protect Against Stroke, Heart Attack in Hypogonadism - Endocrinology Advisor

Repros Therapeutics Inc. (RPRX - Free Report) is expected to report first-quarter 2017 results this month. Lets see how things are shaping up for this quarter.

Repros Therapeutics share price has decreased 28.8% year to date, while the Zacks classified Medical-Biomed/Genetics industry gained 4.7%.

Repros is a development-stage biotech company focused on the development of treatments for hormonal and reproductive system disorders. With no approved products in its portfolio yet, investors are expected to remain focused on pipeline-related updates by the company. Repros pipeline presently comprises enclomiphene and Proellex.

The most advanced candidate in Repros pipeline is enclomiphene, which is currently under review in the EU. The company intends to get the candidate approved for the treatment of secondary hypogonadism. A decision on the approval status of the candidate should be out in 2017.

Moreover, Repros is evaluating enclomiphene for the treatment of low testosterone level in overweight men. The drug was approved in the EU in 2016 for this indication while the phase II study data is under review in the U.S.

Proellex is being evaluated in phase II orally administered trials for the treatment of endometriosis and uterine fibroids under partial clinical hold with low oral dosage. Repros held a discussion with the FDA in April regarding its progress and the next steps in the development of Proellex for the treatment of uterine fibroids. As per the discussion, the FDA will continue to maintain partial clinical hold as the agency internally reviews data related to the effect of the same on the liver. Repros Therapeutics and its panel of liver experts said that they will submit additional information to the FDA and offer a proposed clinical protocol in a month. We expect update on the data at the first quarter conference call.

The company is also evaluating Proellex in a phase IIb study for uterine fibroids by vaginal delivery. However, this study has no clinical hold issues. The company presented positive topline data from this study in November last year.

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What's in the Cards for Repros (RPRX) this Earnings Season? - Zacks.com

Interested participants and investors may access the conference call by dialing either:

1 (855) 656-0926 (U.S.)

1 (412) 542-4198 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Corporate Presentations & Media, at aytubio.com, for 90 days.

A replay of the call will be available for seven days. Access the replay by calling 1 (877) 344-7529 (U.S.) or 1 (412) 317-0088 (international) and using the replay access code 10106783.

About Aytu BioScience

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets two products in the U.S.: Natesto, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T") and ProstaScint (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. Additionally, Aytu is developing MiOXSYS, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets. For more information visit aytubio.com.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaborations. We also refer you to the risks described in "Risk Factors" in Part I, Item 1A of Aytu BioScience, Inc.'s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:

Amato and Partners, LLC

Investor Relations Counsel

admin@amatoandpartners.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aytu-bioscience-to-provide-fiscal-third-quarter-2017-business-update-300450288.html

SOURCE Aytu BioScience, Inc.

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Aytu BioScience to Provide Fiscal Third Quarter 2017 Business Update - PR Newswire (press release)

Sarasota, FL (SBWIRE) 04/25/2017 Zion Market Research, the market research group announced the analysis report titled Male 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.

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.

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

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.

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.

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

Global Male Hypogonadism Market: Regional Segment Analysis

North America U.S. Europe UK France Germany Asia Pacific China Japan India Latin America Brazil The Middle East and Africa

What Reports Provides

Full in-depth analysis of the parent market Important changes in market dynamics Segmentation details of the market Former, on-going, and projected market analysis in terms of volume and value Assessment of niche industry developments Market share analysis Key strategies of major players Emerging segments and regional markets Testimonials to companies in order to fortify their foothold in the market.

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

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Global Male Hypogonadism Market, 20162024: Type. Size, Share, Trends & Forecast Report - satPRnews (press release)

Sarasota, FL (SBWIRE) 04/25/2017 Zion Market Research, the market research group announced the analysis report titled Male 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.

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.

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

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.

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.

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

Global Male Hypogonadism Market: Regional Segment Analysis

North America U.S. Europe UK France Germany Asia Pacific China Japan India Latin America Brazil The Middle East and Africa

What Reports Provides

Full in-depth analysis of the parent market Important changes in market dynamics Segmentation details of the market Former, on-going, and projected market analysis in terms of volume and value Assessment of niche industry developments Market share analysis Key strategies of major players Emerging segments and regional markets Testimonials to companies in order to fortify their foothold in the market.

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

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Global Male Hypogonadism Market, 20162024: Type. Size, Share, Trends & Forecast Report - MilTech

The objective of this study is to investigate the impact of metabolic status on associations of serum vitamin D with hypogonadism and lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH).

A total of 612 men underwent physical examination, biochemical/hormonal blood testing, and transrectal prostate ultrasound. Moreover, the subjects filled out standard questionnaires for identification and grading of LUTS and hypogonadism symptoms. Parameters were statistically compared with independent t-tests and correlation analyses.

Vitamin D levels positively correlated with total testosterone (TT) but not with prostate volume or International Prostate Symptom Score (IPSS). Patients with metabolic syndrome had significantly lower vitamin D levels, which were not correlated with TT, prostate volume, or IPSS. However, vitamin D was positively correlated with TT, and negatively correlated with prostate volume and quality-of-life IPSS in subjects without metabolic syndrome.

The clinical usefulness of vitamin D for treatment of hypogonadism or LUTS/BPH varies according to metabolic status.

The aging male : the official journal of the International Society for the Study of the Aging Male. 2017 Apr 17 [Epub ahead of print]

Sun Gu Park, Jeong Kyun Yeo, Dae Yeon Cho, Min Gu Park

a Department of Preventive Medicine , Gachon University College of Medicine , Incheon , Korea., b Department of Urology , Inje University Seoul Paik Hospital , Seoul , Korea., c Department of Urology , Inje University, Sanggye Paik Hospital , Seoul , Korea.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28414251

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Impact of metabolic status on the association of serum vitamin D with hypogonadism and lower urinary tract symptoms ... - UroToday

BERKELEY, Calif., April 24, 2017 (GLOBE NEWSWIRE) -- XOMA Corporation (XOMA), a pioneer in the discovery and development of therapeutic antibodies, today announced that it has achieved positive Phase 2 proof-of-concept results for X213 in physiological hyperprolactinemia (HPRL). X213 is a monoclonal antibody that neutralizes prolactin action.

This proof-of-concept study was an important milestone in demonstrating the potential efficacy of this novel antibody. We believe that X213 could be a treatment option for a wide range of patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL as the signs and symptoms are similar irrespective of the etiology, said Jim Neal, Chief Executive Officer of XOMA. Consistent with our business strategy, we intend to maximize the value of X213 for shareholders by seeking a license partner for the program.

The Phase 2 study was a multi-center, open-labelled, randomized, single-dose, controlled trial of intravenously administered X213 in women who wished to suppress lactation immediately post-partum. The results of the study indicate that X213, when given as a single 700mg intravenous infusion during the first day post-partum, was effective in suppressing milk secretion, as well as breast engorgement and pain in 100 percent of the treated women. In addition, none of the treated women experienced rebound breast symptomatology during the 21-day study period. While the study was not intended, or powered to show statistical significance, it demonstrated that X213 was: safe and well tolerated; caused no significant adverse events (SAEs); showed favorable pharmacokinetics with a terminal half-life of two weeks and; demonstrated target (prolactin receptor) engagement and mechanism of action confirmation by serum prolactin profiling.

The findings from this proof-of-concept study are encouraging and confirm that X213 inhibits prolactin signaling and thus, may be effective in blocking effects of symptomatic hyperprolactinemia, said Dr. Shlomo Melmed, endocrinologist, Dean of the Medical Faculty and Professor of Medicine, Cedars-Sinai Medical Center, Los Angeles. New classes of drugs such as X213 may offer benefit to the up to 20 percent of patients who do not respond to, or are intolerant of, current standard of care involving dopamine agonist medications.

Prolactin is a multifunctional hormone that is primarily secreted by the pituitary and whose best-known functions are related to lactation and reproduction. In pregnant women, excess prolactin secretion (hyperprolactinemia) occurs to enhance breast development and to induce lactation postpartum. Commonly encountered etiologies of hyperprolactinemia include prolactinoma, medication effect, kidney failure, cystic or granulomatous pituitary lesions, and disorders which interfere with hypothalamic inhibition of prolactin release. Prolactinomas, benign tumors of the pituitary gland, hypersecrete prolactin with significant medical consequences, particularly hypogonadism, infertility and osteoporosis.

About X213 X213 (formerly LFA 102) is a first-in-class allosteric inhibitor of prolactin action. It is a humanized IgG1-Kappa monoclonal antibody that binds to the extracellular domain of the human prolactin receptor with high affinity at an allosteric site. The antibody has been shown to inhibit prolactin-mediated signaling, and it is potent and similarly active against animal and human prolactin receptors.

The Phase 2 study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of X213 in post-partum women. The study was conducted at multiple medical centers in Spain.

About XOMA Corporation XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies. Many of these licenses are the result of the Company's pioneering efforts in the discovery and development of antibody therapeutics. There are more than 20 such programs that are fully funded by partners and could produce milestone payments and royalty payments in the future. In order to maximize its value in a licensing transaction, XOMA continues to invest in X358, an allosteric monoclonal antibody that reduces insulin receptor activity, as the antibody could have a major impact on the treatment of hyperinsulinism. For more information, visit http://www.xoma.com.

Read More

Forward-Looking Statements Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding: X213 as a potential treatment option for patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL; XOMA's portfolio of partnered programs and licensed technologies; XOMA's intent to license X213 and X358; and statements that otherwise relate to future periods. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Continued here:
XOMA Announces Positive Results from its Phase 2 Proof-Of ... - Yahoo Finance

The association between endothelial dysfunction and late onset hypogonadism (LOH) in patients with vasculogenic erectile dysfunction (ED) is not yet well settled. Our objective was to assess the association between LOH and endothelial dysfunction in patients with vasculogenic ED. Throughout 2014-2015 a total of 90 men were enrolled in this cross-sectional observational study. Of them 60 patients with a clinical diagnosis of ED were further subdivided into two equal groups: patients with vasculogenic ED and LOH (A); patients with vasculogenic ED and euogonadal (B). Thirty age-matched men with no ED or hypogonadism were enrolled as control group (C). All patients were subjected to detailed medical and sexual history, total testosterone (TT), calculated free (FT) and bioavailable testosterone (BT), flow cytometric evaluation for endothelial progenitor cells (EPCs) (CD45negative/CD34positive/CD144positive) and endothelial microparticles (EMPs) (CD45negative/CD144positive/annexin V positive). The mean age SD of the three groups A, B and C were 51.311.1, 53.610.6 and 48.35years, respectively, with insignificant age differences (p=0.089). The diagnostic criteria of LOH were adapted according to European male aging study, 2010. The means of TT(ng/mL) were 2.320.21, 6.430.36 and 5.370.30 in groups A, B and C, respectively. There were highly significant differences between group A and groups B and C (p<0.001 for each). The means of EPCs were 0.430.070, 0.220.05 and 0.0320.013 in groups A, B and C, respectively. The means of EMPs were 0.150.029, 0.056 .013 and 0.0140.002 in groups A, B and C, respectively. There were significant differences between group C and groups A and B (p<0.05 for each). This study clearly demonstrated that there is a significant association between LOH and the higher expression of EPCs and EMPs in patients with vasculogenic ED.

Andrology. 2017 May [Epub]

Y A Omar, S E Younis, I Y Ismail, A I El-Sakka

Department of Urology, Suez Canal University, Ismailia, Egypt., Department of Clinical Pathology, Suez Canal University, Ismailia, Egypt.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28409902

Excerpt from:
Testosterone level and endothelial dysfunction in patients with vasculogenic erectile dysfunction. - UroToday

This report, Male Hypogonadism - Pipeline Review, H2 2016, provides an overview of the Male Hypogonadism pipeline landscape.

The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases.

Additionally, the report provides an overview of key players involved in therapeutic development for Male Hypogonadism and features dormant and discontinued projects.

This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from This report 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.

Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report 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.

Accessthis report @ http://www.htfmarketreport.com/buy-now?format=1&report=138812

Scope

- The report provides a snapshot of the global therapeutic landscape of Male Hypogonadism

- The report reviews pipeline therapeutics for Male Hypogonadism by companies and universities/research institutes based on information derived from company and industry-specific sources

- The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

- The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

- The report reviews key players involved Male Hypogonadism therapeutics and enlists all their major and minor projects

- The report assesses Male Hypogonadism therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

- The report summarizes all the dormant and discontinued pipeline projects

- The report reviews latest news related to pipeline therapeutics for Male Hypogonadism

Reasons to access

- Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

- Identify and understand important and diverse types of therapeutics under development for Male Hypogonadism

- Identify potential new clients or partners in the target demographic

- Develop strategic initiatives by understanding the focus areas of leading companies

- Plan mergers and acquisitions effectively by identifying key players and its most promising pipeline therapeutics

- Devise corrective measures for pipeline projects by understanding Male Hypogonadism 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

- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Make an enquiry on this Report @ http://www.htfmarketreport.com/enquiry-before-buy/138812-male-hypogonadism-pipeline-review-3

Table of Contents

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Male Hypogonadism Overview 9

Therapeutics Development 10

Pipeline Products for Male Hypogonadism - Overview 10

Pipeline Products for Male Hypogonadism - Comparative Analysis 11

Male Hypogonadism - Therapeutics under Development by Companies 12

Male Hypogonadism - Therapeutics under Investigation by Universities/Institutes 14

Male Hypogonadism - Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Male Hypogonadism - Products under Development by Companies 18

Male Hypogonadism - Products under Investigation by Universities/Institutes 20

Male Hypogonadism - Companies Involved in Therapeutics Development 21

Antares Pharma, Inc. 21

Clarus Therapeutics, Inc. 22

Endo Pharmaceuticals Inc. 23

EndoCeutics, Inc. 24

Ferring International Center S.A. 25

Forendo Pharma Limited 26

Lipocine Inc. 27

M et P Pharma AG 28

Merck & Co., Inc. 29

Mereo Biopharma Group Plc 30

Millennium Pharmaceuticals Inc 31

Pantarhei Bioscience BV 32

Repros Therapeutics Inc. 33

Variant Pharmaceuticals, Inc. 34

Male Hypogonadism - Therapeutics Assessment 35

Assessment by Monotherapy Products 35

Assessment by Target 36

Assessment by Mechanism of Action 38

Assessment by Route of Administration 40

Assessment by Molecule Type 42

Drug Profiles 44

BGS-649 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

corifollitropin alfa - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

enclomiphene citrate - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

fispemifene - Drug Profile 58

.. Continued

Read Detailed Table of Content @ http://www.htfmarketreport.com/reports/138812-male-hypogonadism-pipeline-review-3

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Recent research: Male hypogonadism - strategic assessment and ... - WhaTech

Infertility can be caused bymany different things. For 25% of couples, a cause can't be identified.

This page covers the possible causes of infertility in men and women.

In women,causes include:

Scarring from surgery

Cervical mucus problems

Fibroids

Endometriosis

Pelvic inflammatory disease

Sterilisation

Medicines and drugs

In men, causes include:

Semen and sperm

Testicles

Sterilisation

Ejaculation disorders

Hypogonadism

Medicines and drugs

This page also has information about:

Unexplained infertility

Infertility is most commonly caused by problems with ovulation, the monthly release of an egg. Some problems stop an egg being released at all, while others prevent an egg being released during some cycles but not others.

Ovulation problems can be a result of:

Pelvic surgery can damage and scar the fallopian tubes, which link the ovaries to the womb.

Cervical surgery can also sometimes cause scarring or shorten the neck of the womb (the cervix).

When you're ovulating, mucus in your cervix becomes thinner so sperm can swim through it more easily. If there's a problem with the mucus, it can make it harder to conceive.

Non-cancerous growths called fibroidsin or around the womb can affect fertility. In some cases, they may prevent a fertilised egg attaching itself to the womb, or they may block a fallopian tube.

Endometriosisis a condition where small pieces of the womb lining (the endometrium) start growing in other places, such as the ovaries. This can damage the ovaries or fallopian tubes andcause fertility problems.

Pelvic inflammatory disease (PID) is an infection of the upper female genital tract, which includes the womb, fallopian tubes and ovaries.

It's often caused by asexually transmitted infection (STI). PID can damage and scar the fallopian tubes, making it virtually impossible for an egg to travel down into the womb.

Some women choose to besterilised if they don't want to have any more children.

Sterilisationinvolves blocking the fallopian tubes to make it impossible for an egg to travel to the womb. It's rarely reversibleif you do have a sterilisation reversed, you won't necessarily become fertile again.

The side effects of some types of medicines and drugs can affect your fertility.

These include:

Illegal drugs, such as marijuana and cocaine, can seriously affect fertility and make ovulation more difficult.

The most common cause of infertility in men ispoor quality semen,the fluid containing sperm that's ejaculated during sex.

Possible reasons for abnormal semen include:

Many cases of abnormal semen are unexplained.

There's a link between increased temperature of the scrotum and reduced semen quality, but it's uncertain whether wearing loose-fitting underwear improves fertility.

The testicles produce and store sperm. If they're damaged, it can seriously affect the quality of your semen.

This can happen asa result of:

Some men choose to have avasectomyif they don't want children or any more children.

It involves cutting and sealing off thetubes that carry sperm out of your testicles (thevas deferens) so your semen will no longer contain any sperm.

A vasectomy can be reversed, but reversals aren't usually successful.

Some men experienceejaculation problems that can make it difficult for them to release semen during sex (ejaculate).

Hypogonadism is an abnormally low level of testosterone, the male sex hormone involved in making sperm.

It could be caused by a tumour, taking illegal drugs, orKlinefelter syndrome, a rare syndrome where a man is born with an extra female chromosome.

Certain types of medicines can sometimes cause infertility problems.

These medicines are listed below:

Illegal drugs, such as marijuana and cocaine, can also affect semen quality.

In the UK, unexplained infertility accounts for around 25% of cases of infertility. This is where no cause can be identified in either the woman or man.

If a cause for your fertility problems hasn't been identified, talk to your doctor about the next steps.

The National Institute for Health and Care Excellence (NICE) recommends that women with unexplained infertility who haven't conceived after two years of having regular unprotected sex should be offered IVF treatment.

The NICE guidance has more about unexplained infertility.

Find out more about fertility tests and how problems are diagnosed.

Page last reviewed: 14/02/2017

Next review due: 14/02/2020

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Infertility - Causes - NHS Choices

Middle-aged and older men (50 years), especially those who are obese and suffer from comorbidities, not uncommonly present with clinical features consistent with androgen deficiency and modestly reduced testosterone levels. Commonly, such men do not demonstrate anatomical hypothalamic-pituitary-testicular axis pathology but have functional hypogonadism that is potentially reversible.

Literature review from 1970 to October 2016.

Although definitive randomized controlled trials are lacking, evidence suggests that in such men, lifestyle measures to achieve weight loss and optimization of comorbidities, including discontinuation of offending medications, lead to clinical improvement and a modest increase in testosterone. Also, androgen deficiency-like symptoms and end-organ deficits respond to targeted treatments (such as phosphodiesterase-5 inhibitors for erectile dysfunction) without evidence that hypogonadal men are refractory. Unfortunately, lifestyle interventions remain difficult and may be insufficient even if successful. Testosterone therapy should be considered primarily for men who have significant clinical features of androgen deficiency and unequivocally low testosterone levels. Testosterone should be initiated either concomitantly with a trial of lifestyle measures, or after such a trial fails, after a tailored diagnostic work-up, exclusion of contraindications, and appropriate counseling.

There is modest evidence that functional hypogonadism responds to lifestyle measures and optimization of comorbidities. If achievable, these interventions may have demonstrable health benefits beyond the potential for increasing testosterone levels. Therefore, treatment of underlying causes of functional hypogonadism and of symptoms should be used either as an initial or adjunctive approach to testosterone therapy.

The Journal of clinical endocrinology and metabolism. 2017 Mar 01 [Epub]

Mathis Grossmann, Alvin M Matsumoto

Department of Medicine, Austin Health, University of Melbourne, Heidelberg, Victoria 3081, Australia., Division of Gerontology and Geriatric Medicine, Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98195; and.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28359097

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A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management. - UroToday

Ads for low-testosterone treatments benefit sales but not necessarily health Science Daily The likelihood of hypogonadism increases with age and can cause symptoms such as low libido, reduced strength, fatigue and depression. It is diagnosed with a blood test together with clinical symptoms and signs, and it is treated with products that ...

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Ads for low-testosterone treatments benefit sales but not necessarily health - Science Daily

The relationships between sport and sexuality in males are of great social and clinical interest, because of sports and motor activities that highly promote social and sexual relationships. Even if few literature exist, two main questions should be taken into account: whether and how physical exercise and sport positively or negatively influence sexual health and behavior and/or whether and how sexual behavior may affect a sub-sequent sport performance. Physical exercise and sport per se can influence, positively or negatively, the hypothalamic-pituitary-testicular axis function and, consequently, the individual's reproductive and/or sexual health. This depends on individual factors such as genetic and epigenetic ones and on different variables involved in the practice of sport activities (type of sport, intensity and duration of training, doping and drug use and abuse, nutrition, supplements, psychological stress, allostatic load, etc.). If well conducted, motor and sport activities could have beneficial effects on sexual health in males. Among different lifestyle changes, influencing sexual health, regular physical activity is fundamental to antagonize the onset of erectile dysfunction (ED). However, competitive sport can lead both reproductive and/or sexual tract damages and dysfunctions, transient (genital pain, hypoesthesia of the genitalia, hypogonadism, DE, altered sexual drive, etc.) or permanent (hypogonadism, DE, etc.), by acting directly (traumas of the external genitalia, saddle-related disorders in cyclists, etc.) or indirectly (exercise-related hypogonadism, drug abuse, doping, stress, etc.). Sexual activities shortly performed before a sport competition could differently influence sport performance. Due to the few existing data, it is advisable to avoid an absolute pre-competition sexual abstinence.

Journal of endocrinological investigation. 2017 Mar 22 [Epub ahead of print]

P Sgr, L Di Luigi

Unit of Endocrinology, Section of Health Sciences, Department of Movement, Human and Health Sciences, University of Rome "Foro Italico", Rome, Italy., Unit of Endocrinology, Section of Health Sciences, Department of Movement, Human and Health Sciences, University of Rome "Foro Italico", Rome, Italy. .

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28332171

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Sport and male sexuality. - UroToday

Dive Brief:

"Low-T" was not a common term before 2009, but direct-to-consumer advertising by the makers of testosterone medications made it a household condition, despite there being little evidence of an actual problem.

Testosterone gels and creams are typically approved for men with pathological hypogonadism, a low hormone condition that can arise after chemotherapy for prostate cancer. Yet, the pharmaceutical industry spent years advertising the products to treat an unsubstantiated "lifestyle" condition for men who werent feeling quite "manly" or had a low sex drive, despite little to no safety or efficacy data supporting these claims.

"Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household," noted the JAMA report. "Non-branded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing."

The "Low-T" craze became an exercise in how pharma companies can abuse the direct-to-consumer advertising paradigm. DTC ads are common across therapeutics areas in the U.S., but generally not allowed in other countries. The practice of advertising drugs directly to patients has long been criticized by those within and outside the industry.

AbbVie precursor Abbott Laboratories acquired AndroGel, a major player in the low-T segment, in 2010 from Solvay Pharmaceuticals. The commercialization engine at AbbVie then began promoting the drug. By 2013, AndroGel became AbbVies best-selling drug behind its blockbuster rheumatoid arthritis treatment Humira, with more than $1 billion in sales. The drug had grown by more than 55% during the course of 2012 alone, largely driven by the off-label use in "Low-T" patients.

AndroGel was the dominant player in this space until the Food and Drug Administration began cracking down on the treatments. In 2016, the FDA issued its third warning in three years about the testosterone category, reporting that abuse of the treatments could cause heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.

The first of the product liability suits for AndroGel are expected to begin in June of this year, alleging that the company did not adequately warn of the risks of the drug and promoted it off-label for the use of "Low-T."

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JAMA confirms DTC drove 'Low-T' craze - BioPharma Dive

Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300ng/dl at two consecutive measurements were included. Study duration was 9months (000023: 3months; 000077: 6months). Starting dose of TG (46mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (Cmax ) >1500ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. Cmax >1500ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce Cmax is warranted while maintaining the average steady state total testosterone concentration.

Andrologia. 2017 Mar 10 [Epub ahead of print]

L Belkoff, G Brock, D Carrara, A Neijber, M Ando, J Mitchel

Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA., Division of Urology, Department of Surgery, Western University, London, ON, Canada., Ferring Galenisches Labor AG, Gewerbestrasse, Allschwil, Switzerland., International Pharma Science Center, Ferring Pharmaceuticals, Copenhagen, Denmark., Ferring International PharmaScience Center US Inc., Parsippany, NJ, USA., Target Health Inc, New York, NY, USA.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295450

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Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies. - UroToday

To alleviate late-onset hypogonadism, testosterone treatment is offered to suitable patients. Although testosterone treatment is commonly given to late-onset hypogonadism patients, there remains uncertainty about the metabolic effects during follow-ups. We assessed the associations between testosterone treatment and wide range of characteristics that included hormonal, anthropometric, biochemical features. Patients received intramuscular 1,000mg testosterone undecanoate for 1year. Patient anthropometric measurements were undertaken at baseline and at each visit, and blood samples were drawn at each visit, prior to the next testosterone undecanoate. Eighty-eight patients (51.113.0years) completed the follow-up period. Testosterone treatment was associated with significant increase in serum testosterone levels and significant stepladder decrease in body mass index, total cholesterol, triglycerides and glycated haemoglobin from baseline values among all patients. There was no significant increase in liver enzymes. There was an increase in haemoglobin and haematocrit, as well as in prostate-specific antigen and prostate volume, but no prostate biopsy intervention was needed for study patients during 1-year testosterone treatment follow-up. Testosterone treatment with long-acting testosterone undecanoate improved the constituents of metabolic syndrome and improved glycated haemoglobin in a stepladder fashion, with no adverse effects.

Andrologia. 2017 Mar 10 [Epub ahead of print]

O Canguven, R A Talib, W El Ansari, D-J Yassin, M Salman, A Al-Ansari

Department of Urology & Andrology, Hamad General Hospital, Doha, Qatar., Department of Surgery, Hamad General Hospital, Doha, Qatar., Institute of Urology & Andrology, Norderstedt-Hamburg, Germany.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28295504

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Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid ... - UroToday

Five recently published studies, including four from the National Institutes of Health-supported large-scale Testosterone Trials, provide new insight on testosterone replacement therapys effect on cardiovascular health, as well as anemia, cognitive function, and volumetric bone density and strength.

The effect of TRT on cardiovascular health in men with hypogonadism has been an unresolved issue considering the conflicting findings and design limitations of available research. Two of the new studies generated differing results, and while both studies had notable strengths, they had important weaknesses as well.

The Cardiovascular Trial of the Testosterone Trials (TTrials) was a prospective, randomized, double-blind, placebo-controlled study that included 170 men aged 65 years and older with hypogonadal symptoms and low testosterone (<275 ng/dL) appearing to be age-related. Participants were randomized to use testosterone gel or placebo gel for 1 year.

Noncalcified coronary artery plaque volume determined by coronary computed tomographic angiography, a surrogate for coronary atherosclerosis, was investigated as the primary endpoint. Data from 138 men who completed the study showed the median plaque volume increased significantly more in the TRT-treated men compared with the control group (204 mm3 to 232 mm3 vs 317 mm3 to 325 mm3; estimated difference, 41 mm3, p=.003) (JAMA 2017; 317:708-16). Compared with controls, the TRT-treated group also had a significantly greater increase in total plaque volume, but there was no difference between groups in the change in coronary artery calcium score.

Related - Testosterone therapy's big week: One urologist's perspective

The strengths of the trial include its prospective, randomized design, selection of men with unequivocally low testosterone, and high retention rate. However, it used surrogate outcomes for cardiovascular events and was not of sufficient size or duration to investigate risk of major adverse cardiovascular events, said J. Kellogg Parsons, MD, MHS, of the University of California, San Diego, an investigator for the TTrials and a coauthor for previously published TTrials research. Larger studies are needed to understand the clinical implications of the radiologic findings.

Separately, researchers from Kaiser Permanente California analyzed cardiovascular event rates in a cohort of men age 40 years who had documented androgen deficiency (coded diagnosis or morning serum total testosterone <300 ng/dL). They compared men who had been dispensed a prescription for any form of TRT (n=8,808) and those who were never dispensed TRT (n=35,527). In the TRT group, men had a mean age of 58.4 years, 1.4% had a history of a cardiovascular event, and median follow-up was 4.2 years. Men who never received TRT had a mean age of 59.8 years, 2.0% had a prior cardiovascular event, and median follow-up was 3.2 years.

Multivariable Cox proportional hazard analysis using propensity score methodology to balance baseline characteristics found a 33% significantly reduced risk (p<.001) for the primary outcome (composite cardiovascular endpoint including acute myocardial infarction, coronary revascularization, unstable angina, stroke, transient ischemic attack, and sudden cardiac death) in the TRT group compared with controls (JAMA Intern Med, epub., Feb. 21, 2017). The result was similar in additional analyses comparing risks for all but one of the individual events and in subgroups of men <65 years, 65 years, with a cardiovascular event history, without a cardiovascular event history, and looking at defined follow-up intervals.

T. Craig Cheetham, PharmD, MS, of Southern California Permanente Medical Groups department of research and evaluation, Pasadena, is lead author of the paper, which was not part of the TTrials. He told Urology Times, Our findings suggest that TRT is safe in androgen-deficient males. However, based on findings from previous studies, we believe caution is warranted when treating frail elderly males and those with high cardiovascular risk.

Commenting on the study design, Dr. Cheetham noted that its relatively large cohort of androgen-deficient men treated with TRT represents its major strength. In addition, the TRT-treated group was well matched to the control group, and the results were robust in the planned stratified and sensitivity analyses.

However, he acknowledged that because it was an observational study, the reported data only identify associations and cannot determine cause and effect. In addition, the study could not control for potential bias from unmeasured confounding.

Continued here:
TRT and heart health: Conflicting findings published - ModernMedicine

Brandon Ramirez, 28, of Colonial Heights, has exceeded expectations with help from his mother and family

COLONIAL HEIGHTS Sitting in her dining room on a warm February afternoon, LaDonna DeStazio reflects on her familys journey that has led them to Colonial Heights. Her son, Brandon Ramirez, 28, sits beside her, confined to a special wheelchair. He was not expected to live past the age of 12.

It was emotionally hard, but never physically hard, said LaDonna DeStazio on having to care for her son. People used to say all the time gosh it must be so hard for you. You do what you do as a mom.

LaDonna has given Brandon round-the-clock care for many years of his life, as his condition has deteriorated.

He can use his voice sometimes, mentally hes all there, but physically he has declined, she said.

What Brandon Ramirez has is called 4H syndrome, a rare genetic disorder with only 40 known cases in the U.S. The name 4H is short for hypomyelination, hypogonadotropic hypogonadism, and hypodontia. According to the Leukodystrophy Resource and Research Foundation, hypomyelination means there is a lack of myelin in the central nervous system. Hypogonadotropic hypogonadism results in a lack of normal puberty development because the central nervous system is not working properly. Hypodontia means that not all teeth are present.

Symptoms of 4H include late walking, problems with balance and motor skills, and an absence of normal development during puberty. Due to the rarity of the syndrome, there is no known cure.

For the first decade of his life, doctors were unable to pinpoint Brandons disorder. LaDonna DeStazio first went to doctors in 1994 when Brandon was in kindergarten and he first started having tremors. Her family was living in Colorado at the time.

When we first took him to the doctors, they had no clue, said LaDonna. He was at the childrens hospital and they were doing all these tests. They said he had something called essential tremors.

When Brandon began struggling with his walking when he was 8, LaDonna took him back to the doctors.

At that point, thats when they said he had some form of vanishing white matter disease, said LaDonna.

Vanishing white matter refers to the deterioration of tissue in the brain, which is normally due to aging. Doctors told LaDonna that kids with that type of disease dont normally live past the age of 12. Despite the dire diagnosis, Brandon was still able to live a relatively normal childhood.

By the time he was 12, he really hadnt declined, said LaDonna. He was still able to ride a bike, his walking was fine. He did everything a normal kid could do, the only sign was really the gait when he walked.

At that point, when LaDonna took Brandon back to the doctors, they found no vanishing white matter. Doctors were again at a loss.

They were like We dont know what to tell you, we dont know what he has, said LaDonna. And at that point, I had done all this research, trying to figure out what the heck is going on with him, and was coming up with nothing. Nobody knew.

Brandon began to decline as he entered high school, as he had not properly gone through puberty due to the 4H. Despite his situation, Brandon was able to persevere with the help of his family and his mother, who attended school with him for the last three months before he graduated from Rangeview High School in Aurora, Colorado in 2007. Brandon was able to walk across the stage to receive his diploma. Brandon is proudly able to nod his head as his mother mentions that he had one of the highest SAT scores of all the students in his high school. Though despite the joy, he continued to worsen.

We were basically told in 2007 that he wouldnt make it, said LaDonna.

In 2008 after Brandon had declined to almost nothing according to LaDonna, she received an email from Dr. Adeline Vanderver of the Childrens National Health System in Washington D.C. Vanderver confirmed that the diagnosis that had eluded doctors was most likely 4H syndrome, and advised the family to relocate to the East Coast.

In the years after the diagnosis, Brandon was able to bounce back, even graduating from college with a degree in horticulture in 2009.

LaDonna having to move Brandon from Colorado coincided with her being introduced to Jeff DeStazio, who she met through a mutual friend. By then, LaDonna (who changed her last name from Ramirez) had been divorced from her first husband. Her other two children, Elizabeth and Anthony, are grown and still live in Colorado.

I really dont recall how it all happened. I needed to be on the East Coast: I basically called and was like Im coming to stay with you said LaDonna smiling. He was fresh off a divorce at the time, and I knew how to be a mom. So I would help him out with his girls.

LaDonna and Jeff were married in 2012. Along with Brandon, LaDonna and Jeff reside in their Colonial Heights home with Jeffs daughter Paige, who is 19. Jeffs other daughter Kylie is currently serving in the Marines.

The DeStazio household could certainly be described as unique. Two service dogs, Laychey and Bryndal, help Brandon with some of his day-to-day activities. Though the little puppies are not what you would normally tag as service dogs, with both of them being about a foot long and maybe 15 pounds. Brandons comfort kitties - Rizzie and Stash rest sleepily on his lap.

The DeStazios cant go out as much in recent years: LaDonna notes that car rides are a big thing, but the family still frequents occasional trips to goodwill and the mall. Brandon also enjoys watching the birds of local Buddy Waskey when he free-flies his Blue Throated Macaws. Paige DeStazio noted that she and Brandon often watch movies together.

I try to listen to music with him, and show him whats current, said Brandons cousin James Molica. Though its hard sometimes to tell what hes thinking.

Treating Brandon remains a challenge, as there is no set medication or treatment that works definitively for 4H.

A lot of it is still a guessing game, said LaDonna.

He has been taking testosterone and growth hormone on and off for many years. Brandon has also used a feeding tube at various times.

LaDonna also credits some Colonial Heights residents for assisting the family, as the ramp leading into the house and the stair chair that gets Brandon up the stairs were donated.

Despite the long road her family has taken, LaDonna firmly believes that the upbeat spirit they carry has led to Brandon reaching a point doctors never thought he would.

We chose to not let it be disruptive in our lives, said LaDonna. Not to let it change us as a family. We chose to focus on what he can do and not get depressed over the fact that oh Im not doing this.'

John Adam may be reached at jadam@progress-index.com or 804-722-5172.

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Family strength helps Brandon Ramirez persevere - Progress Index

MMAjunkie.com

USADA notifies Ben Rothwell of potential anti-doping violation, putting UFC 211 status in jeopardy MMAjunkie.com Doctors told me TRT was something that could stop the hypogonadism from degrading my body, he wrote in a statement to MMAjunkie at the time. I am not going to fight the suspension as I feel ultimately it is my responsibility to make sure I stay ... and more »

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USADA notifies Ben Rothwell of potential anti-doping violation, putting UFC 211 status in jeopardy - MMAjunkie.com

Home Men's Health Declining libido? This may be the cause

Contrary to popular belief, menopause is not just a female problem. Male menopause the nickname for late-onset hypogonadism that occurs as a mans testosterone levels wane with age can mimic its female counterpart and include symptoms such as hot flashes, disrupted sleep, fatigue, and flagging libido, as well as moodiness.

Low testosterone levels affect as much as 25 percent of middle-aged men, making the condition more common than it may seem. However, unlike the rapid changes women experience, the decline in testosterone happens more gradually which can make symptoms difficult to spot and attribute to the correct cause. Being more tired and not sleeping well may lead you to think that you need a new mattress or should cut back on the caffeine. Because of hot flashes, you may think the room is warmer or youre coming down with a fewer. And your flagging libido could potentially be related to that fatigue or increased stress. (Siberian secret refuels energy from within.)

As these symptoms are all so general and easy to overlook, hypogonadism (insufficient production of testosterone) can be overlooked and leave its sufferers confused and agitated. Luckily, a simple blood test performed by your doctor will tell you if your testosterone levels are lower than average, and there are treatments available to get your levels back to where they should be to relieve symptoms.

However, these treatments have proven most effective in men who have been diagnosed with conditions like testicular cancer and the merit of treating men with low testosterone due to aging is still up for debate. In the guidelines released by the Endocrine Society, it is recommended that physicians only prescribe medical testosterone therapy for men who are experiencing consistently low levels, and significant sexual and physical complications. (Boost your testosterone naturally with this one thing.)

Related: 5 sure-fire ways to boost your libido

Related Reading:

Low libido? It could be something more serious

Spark your libido with these 6 fixes

http://www.health.com/health/condition-article/0,,20408367,00.html

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Declining libido? This may be the cause - Bel Marra Health

Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone.

This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT in prostate cancer patients in three European countries (Italy, France, Switzerland).

In this 24-month observation study we enrolled 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer. All patients aged 55 years and had a dual-energy X-ray absorptiometry (DEXA) T-score <-1.0 (hip or spine, measured within last 2 years) and 1 fragility fracture. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg weekly) for 2 years. All patient received supplemental vitamin D (600 IU per day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), Bone Mineral Density (BMD), fracture incidence, Visual Analogue Scale (VAS) score for back pain, and Short Form-8 (SF-8TM) health survey score for health-related quality of life (HRQoL). Percent changes from baseline in BTMs and BMD were assessed using the paired t test; a P-value 0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs -1.1% with alendronate (P<0.001). New vertebral fractures developed in fewer patients in the denosumab group than in the alendronate group during the 24-month period, although this difference was not significant (P=0.10). Back pain significantly (P<0.001) improved from baseline at all time points during the study in both study groups. SF-8 health survey scores significantly improved following treatment with both drugs. Incidence of adverse drug reactions were similar in both groups.

In our study denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.

Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases. 2017 Feb 10 [Epub]

Carlo Doria, Paolo Tranquilli Leali, Federico Solla, Gianluca Maestretti, Massimo Balsano, Robero Mario Scarpa

Orthopaedic Department, University of Sassari, Italy., Orthopaedic Department, Paediatric Hospital Nice CHU-Lenval, France., Spinal Unit - Cantonal Hospital Fribourg, Switzerland., Orthopaedic Department, Santorso Hospital AUSSL 4 Schio, Italy., University of Turin, Italy.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/28228781

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Denosumab is really effective in the treatment of osteoporosis secondary to hypogonadism in prostate carcinoma ... - UroToday

News | March 01, 2017 | Cardiac Imaging, CT

Coronary CT angiography (CCTA) shows older men who use testosterone gel have a significantly greater increase in coronary artery noncalcified plaque volume, according to a study published in the Journal of the American Medical Association.

Researchers from nine states in the U.S. undertook a double-blinded, placebo-controlled trial to determine if testosterone use among older men slowed progression of noncalcified coronary artery plaque volume or increased cardiovascular risk.

A total of 138 men completed the study out of 170 who enrolled. The men were aged 65 or older with an average of two serum testosterone levels lower than 275 ng/dL and had symptoms suggestive of hypogonadism. The subjects received testosterone gel dose adjusted to maintain the testosterone level in the normal range for young men (73 subjects), or placebo gel for 12 months (65 subjects).

The primary outcome was noncalcified coronary artery plaque volume, as determined by CCTA, and secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to more than 400 Agatston units, with higher values indicating more severe atherosclerosis). At baseline, 70 men (50.7%) were found to have a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis.

Coronary CT angiogram results showed testosterone treatment compared with placebo was associated with a significantly greater increase in noncalcified plaque volume from baseline to 12 months, from median values of 204 mm3 to 232 mm3 versus 317 mm3 to 325 mm3, respectively, with an estimated difference of 41 mm3. For the secondary outcomes, the median total plaque volume increased from baseline to 12 months from 272 mm3 to 318 mm3 in the testosterone group versus from 499 mm3 to 541 mm3 in the placebo group, with an estimated difference of 47 mm3. The median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group versus 494 to 503 Agatston units in the placebo group, with an estimated difference of 27 Agatston unit. No major adverse cardiovascular events occurred in either group.

The researchers concluded that older men with symptomatic hypogonadism who undergo treatment with testosterone gel for one year have a significantly greater increase in coronary artery noncalcified plaque volume. Larger studies are needed to understand the clinical implications of this finding, they wrote.

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Increased Plaque Volume on CCTA in Older Men Who Use Testosterone Gel - Diagnostic Imaging

Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot Testosterone P&T Community We continue to believe QST could be an excellent treatment option for men with hypogonadism based upon the positive pharmacokinetic and safety data produced in the two phase three studies now on file with the FDA. In addition to virtually eliminating ... and more »

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Antares Pharma Announces FDA Acceptance of New Drug Application for Quickshot Testosterone - P&T Community