/publications/issue/2005/2005-02/2005-02-9277

Female Testosterone Patch Data Are Under Review

Author:

The FDA has granted priority review to Intrinsa (testosterone transdermal system). It is an investigational female testosterone patch for the treatment of hypoactive sexual desire disorder (HSDD) in surgically menopausal women. If approved, Intrinsa (Procter & Gamble Pharmaceuticals) would be the first prescription treatment for HSDD.

HSDD is defined as a lack of sexual desire that causes a woman personal distress and is one of the most common female sexual health problems. The data sent to the FDA were based on findings from 2 phase 3 clinical trials presented recently at the 52nd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists and the 86th Annual Meeting of the Endocrine Society. The 2 24-week, randomized, double-blind, placebo-controlled, multicenter studies included 1000 surgically menopausal women with HSDD. The participants ranged from 20 to 70 years of age and were receiving either oral or transdermal estrogen therapy. The study tested the efficacy and safety of the female testosterone patch.