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FDA approves testosterone gel for hypogonadism
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The FDA has approved a clear, odorless gel for the treatment of hypogonadism. According to a company press release, the topical gel is slated to hit the market in early 2011.
Approval is based on results of a 90-day, multicenter, open-label, non-comparative, pivotal phase 3 trial in men with hypogonadism. According to the data, 78% of patients using the gel had an average serum total testosterone concentration within the normal range at day 90. The most common adverse event was reaction at the application site. The safety and efficacy of the treatment has not been evaluated in men younger than 18 years.
The gel (Fortesta, Endo Pharmaceuticals) comes in a metered-dose pump and is applied to the front and inner thigh.
Women and children should avoid contact with areas where the gel has been applied, and those with breast cancer or prostate cancer should not use the gel.
Possible adverse events include: enhanced systems of enlarged prostate; possible increased risk for prostate cancer; lower sperm count associated with using large doses of the gel; swelling of the ankles, feet or body, with our without heart failure; enlarged or painful breasts; sleep apnea; increased red blood cell count and blood clots in the legs. The most common adverse events are redness or irritation at application site, increased prostate-specific antigen and abnormal dreams.
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