Testosterone gel receives FDA approval

January 7, 2011

The FDA has approved a new testosterone gel (Fortesta) for the treatment of hypogonadism.

The FDA has approved a new testosterone gel (Fortesta) for the treatment of hypogonadism.

The gel is clear, colorless, and odorless. It is gently applied with one finger to the front and inner thighs, and not the upper body. It comes in a metered-dose pump that delivers the correct dose per complete depression.

In a 90-day, multicenter, open-label, phase III trial involving men with hypogonadism, 78% of patients using the gel had an average serum total testosterone concentration within the normal range at day 90. The most common side effect was application site reactions.

"Declining blood levels of testosterone can occur in men beginning as early as age 40," said Adrian Dobs, MD, of Johns Hopkins University School of Medicine, Baltimore, who served as principal investigator of the Fortesta gel phase III clinical trial. "The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems. Fortesta gel is an important new treatment option for men who are diagnosed with low testosterone."