Data from a landmark Phase III safety and efficacy study of 562 women showed treatment with an investigational female testosterone patch significantly increased satisfying sexual activity and desire in patients with Hypoactive Sexual Desire Disorder (HSDD), who previously had both ovaries removed. HSDD is defined as a lack of sexual desire that causes a woman personal distress.
The preliminary findings of the study were presented today during the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG). "As physicians who treat menopausal women, this news is very exciting.
We know there is a tremendous medical need to address those suffering with low sexual desire, particularly those women having experienced surgical menopause," said James A. Simon, M.D., lead study investigator and Clinical Professor of Obstetrics and Gynecology at the George Washington University in Washington, D.C., and Medical Director at The Women's Health Research Center in Laurel, Maryland. "We have been waiting a long time for advances in female sexuality research that could lead to FDA-approved treatments. We hope we are one step closer to providing an effective therapeutic option."
The study of 562 surgically menopausal women with HSDD showed patients receiving testosterone via a transdermal patch experienced a 74 percent increase in the frequency of total satisfying sexual activity, as well as a 56 percent increase in sexual desire versus baseline. The increases were statistically significant versus baseline and placebo.
Significant improvements were also seen in arousal, orgasm, pleasure, responsiveness, concerns, self-image and distress levels in women using the testosterone patch. Overall, adverse event reports were comparable to placebo, the most common being application site reaction, upper respiratory infection and headache.