FDA Clears Testosterone Gel

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The FDA has approved a testosterone replacement therapy gel, a colorless and odorless preparation applied with one finger to the front and inner thighs.

The gel, marketed as Fortesta Gel by Endo Pharmaceuticals, comes in a metered-dose pump that delivers the correct dose per complete depression.

In a 90-day multicenter open-label, non-comparative phase 3 trial that enrolled men with hypogonadism, 78% of those using the gel had an average serum total testosterone level within the normal range at day 90. The most common adverse effect observed in the trial was application site reactions.

Men who have or might have prostate cancer are advised not to use the gel.

Endo cautioned that use of the gel may worsen signs and symptoms of benign prostatic hyperplasia.

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