Hypogonadism News and Research

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Testicular failure, also known as primary hypogonadism, is an uncommon condition that is characterized by the inability of the testicles to produce sperm and the male hormone testosterone. The are many factors that have been postulated as causes of the condition, which give rise to a wide array of signs and symptoms. These factors can sometimes make diagnosis as well as treatment of testicular failure a challenging problem.

Vitamin D deficiency may be an important risk factor for erectile dysfunction

A paper just published hypothesizes that vitamin D deficiency may be an important risk factor for erectile dysfunction (ED).

7 Jun 2012

JS Genetics announces availability of XCAT-KS buccal swab test

JS Genetics announces the availability of XCAT-KS, its proprietary buccal swab test for the diagnosis of Klinefelter syndrome (KS) and other male sex chromosome aneuploidies.

3 May 2012

MAPK/ERK2 pathway plays a major role in mediating testosterone's effects

Testosterone, the primary male sex hormone, appears to have antidepressant properties, but the exact mechanisms underlying its effects have remained unclear. Nicole Carrier and Mohamed Kabbaj, scientists at Florida State University, are actively working to elucidate these mechanisms.

2 Apr 2012

BioSante third quarter net loss increases to $12.7 million

BioSante Pharmaceuticals, Inc. today announced financial results for the third quarter ended September 30, 2011 and provided an update on the Company's pipeline.

9 Nov 2011

Watson receives FDA approval for Androderm lower-dose formulations

Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration approved its Androderm (testosterone transdermal system) 2 mg and 4 mg formulation.

21 Oct 2011

FDA approves Abbott's AndroGel for hypogonadism treatment in men

Abbott announced today that the U.S. Food and Drug Administration has approved AndroGel 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%.

30 Apr 2011

FDA accepts Teva's NDA filing of Bio-T-Gel for male hypogonadism

BioSante Pharmaceuticals, Inc. today announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd.. The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.

15 Apr 2011

Lilly's Axiron testosterone replacement therapy now available in US pharmacies

Eli Lilly and Company announced today that Axiron® (testosterone) topical solution is available in pharmacies throughout the United States. Axiron is a prescription medicine used to treat adult males that have low or no testosterone. Safety and efficacy of Axiron in males younger than 18 years of age have not been established.

1 Apr 2011

Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

Endo Pharmaceuticals announced that FORTESTA Gel – recently approved by the U.S. Food and Drug Administration for the treatment of low testosterone, or 'Low T' in adult males – is now available by prescription in pharmacies across the country.

3 Mar 2011

Endo fourth quarter total revenues increase 31% to $511 million

Endo Pharmaceuticals today reported financial results for the fourth quarter 2010.

28 Feb 2011

Lipocine files new patent applications in support of oral testosterone product for hypogonadism

Lipocine Inc. announced today that in addition to its issued patents involving oral testosterone, it has recently filed two new patent applications in support of its oral testosterone product for hypogonadism, also known as low testosterone (low T). These applications cover Lipocine's novel oral testosterone product (LPCN 1021) being developed to overcome the issues with currently marketed topical, parenteral, and transdermal testosterone products.

28 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

Single injection of morphine to fight persistent pain reduces testosterone level: Research

A single injection of morphine to fight persistent pain in male rats is able to strongly reduce the hormone testosterone in the brain and plasma, according to a new paper published in Molecular Pain.

4 Nov 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

Low testosterone levels to blame for low libido, fatigue and weight gain

While most frequently associated with women's health, age-related hormone changes, often dubbed menopause, can occur in men as well, causing symptoms of fatigue, mood swings, decreased desire for sex, hair loss, lack of concentration and weight gain. Experts estimate that more than 5 million men are affected, yet worry the number may be considerably higher since symptoms are frequently ignored.

21 Aug 2010

Repros Therapeutics requests Type B Meeting to review Androxal Phase III protocols

Repros Therapeutics Inc. today announced that the Company has requested a Type B Meeting in order to review the Company's Phase III protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

18 Aug 2010

Repros receives US patent for Androxal

Repros Therapeutics Inc. today announced the US Patent and Trademark office has issued U.S. Patent No. 7,759,360 for Androxal, the Company's lead program for the treatment of low testosterone in men. This patent specifically claims methods and materials for the treatment of testosterone deficiency in men with secondary hypogonadism. Repros has over 35 issued or pending US and European patents involving Androxal.

11 Aug 2010

Repros Therapeutics receives positive feedback from FDA for Androxal

Repros Therapeutics Inc. today announced that the Company has received positive written feedback from the FDA (the "Agency") regarding the Company's drug candidate Androxal. The Agency concurred with Repros' indication statement for the use of Androxal in the treatment of secondary hypogonadism in men wishing to preserve fertility.

9 Aug 2010

Endo Pharmaceuticals total revenues for second-quarter 2010 increase 6% to $396.5 million

Endo Pharmaceuticals today reported financial results for the second quarter 2010. Total revenues during the second quarter of 2010 increased 6 percent to $396.5 million, compared with $373.1 million in the same quarter of 2009. Net income for the three months ended June 30, 2010 was $51.5 million, compared with $30.0 million in the comparable 2009 period.

30 Jul 2010