Hypogonadism News and Research

RSS

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.

Endo responds to FDA Complete Response letter for FORTESTA NDA

Endo Pharmaceuticals has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.

1 Jul 2010

Scientists identify symptoms associated with late-onset hypogonadism

Scientists have for the first time identified the symptoms associated with what has been termed late-onset hypogonadism or 'male menopause' caused by a reduction in testosterone production in ageing men.

17 Jun 2010

Repros to appeal NASDAQ for additional time to regain compliance

On June 15, 2010, Repros Therapeutics Inc. received notification from NASDAQ that it has not regained compliance with NASDAQ Listing Rule 5550(a)(2) and, unless the Company appeals NASDAQ's decision, trading of the Company's common stock will be suspended and the Company's securities will be delisted from the NASDAQ Stock Market.

17 Jun 2010

Obese men more likely to have low testosterone than non-obese men: HIM study

Obesity, a condition linked to heart disease and diabetes, now appears to be associated with another health problem, but one that affects men only -- low testosterone levels.

4 May 2010

Lipocine announced receipt of $2M development milestone payment from Abbott

Lipocine Inc. announced today the receipt of a $2 million development milestone payment from Abbott under the terms of its Licensing Agreement to develop and commercialize an oral testosterone product for hypogonadism, also known as low testosterone.

21 Apr 2010

Repros Therapeutics announces response to FDA critique on proposed Phase II Androxal study

Repros Therapeutics Inc. today announced that the Company is sending a reply to the FDA's Division of Metabolism and Endocrinology Products following the Company's receipt of FDA's comments on the proposed Phase II study of Androxal® (enclomiphene) in the treatment of Type II diabetes under Repros' open IND. On February 2, 2010 the Company announced that Repros received confirmation from the Agency that the new IND is effective.

1 Apr 2010

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Eli Lilly and Company and Acrux announced today that they have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON™).

16 Mar 2010

BeaconEquity.com: BPAX incurs net loss of $6.4M for quarter ended September 30, 2009

BeaconEquity.com announces an investment report featuring biotechnology company BioSante Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.

12 Mar 2010

Androxal Type C meeting: Repros Therapeutics receives FDA’s version of minutes

Repros Therapeutics Inc. today announced that the Company has received the FDA’s version of the minutes of the Type C meeting held on January 25, 2010. The minutes confirmed the Company’s interpretation of the points the Agency made during the meeting. In correspondence from the FDA prior to the meeting the Agency noted that they could not currently agree with the Company’s stated indication for the use of Androxal® in the treatment of secondary hypogonadism in men wishing to preserve fertility.

4 Mar 2010

Trimel BioPharma Holdings updates business developments

Trimel BioPharma Holdings Inc. is today providing an update on a number of operational items that have contributed significantly to advancing the Company and achieving its initial objectives.

10 Feb 2010

Repros Therapeutics submits Androxal revised indication statement to the FDA

Repros Therapeutics Inc. today announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA’s Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state.

8 Feb 2010

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Repros Therapeutics Inc. today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial.

3 Feb 2010

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone.

3 Dec 2009

Ligand Pharmaceuticals' SARM LGD-4033 study data presented at the Gerontology Society of America meeting

Ligand Pharmaceuticals Incorporated today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal models of male hypogonadism and postmenopausal osteoporosis.

20 Nov 2009

Repros Therapeutics signs settlement agreement with major creditors

Repros Therapeutics today announced that the Company has entered into a settlement agreement with its major creditors for the large majority of the debt incurred associated with the recently suspended Proellex® clinical program.

30 Oct 2009

Testicular cancer survivors at risk of effective treatment

Testicular cancer survivors can face an increased risk of long-term illness, not because of the malignancy, but the highly effective treatment they receive, according to a study in the urology journal BJUI.

20 Oct 2009

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

BJUI: Testicular cancer survivors face an increased risk of long-term illness due to effective treatment

19 Oct 2009

Repros announces results of its Androxal efficacy study for secondary hypogonadism

Repros Therapeutics Inc. today announced results from an exploratory, efficacy and safety study of its oral investigational product, enclomiphene citrate (Androxal®), in men with secondary hypogonadism who were receiving testosterone replacement treatment. Secondary hypogonadism is a deficiency state in which the male hormone testosterone goes below the normal range, even in aging men, due to inadequate stimulation of the testes by the pituitary.

7 Oct 2009

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

Australian company, Acrux, today announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

29 Sep 2009