Intrinsa patch increases sexual desire in menopausal women

Data released from a second, large-scale safety and efficacy study showed treatment with Intrinsa, an investigational female testosterone patch, significantly increased satisfying sexual activity and sexual desire in menopausal women with Hypoactive Sexual Desire Disorder (HSDD), and 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 at ENDO 2004, the 86th Annual Meeting of The Endocrine Society.

"These impressive study results add to the strong foundation of evidence around the benefits of testosterone therapy via a patch for restoring sexual desire in surgically menopausal women," said John Buster, M.D., lead study investigator and Director of the Division of Reproductive Endocrinology and Infertility at the Baylor College of Medicine in Houston, Texas. "Back-to- back trial results of this depth and consistency in the field of female sexual function are important for physicians and patients alike. The surgically menopausal women I see in my practice everyday paint a very clear picture of how common and concerning a loss of desire can be, and how real the need is for therapeutic options."

The study of 533 surgically menopausal women with HSDD showed patients receiving testosterone via a transdermal patch experienced a statistically significant increase (p=0.001) in the frequency of total satisfying sexual activity, as well as a statistically significant increase (p=0.0006) in sexual desire versus placebo. Significant improvements were also seen in arousal, orgasm, pleasure, responsiveness, concerns, self-image and distress levels for women using the female testosterone patch. Overall, adverse events (AEs) were similar in the testosterone and placebo groups. Although the overall incidence of androgenic AEs was low, the incidence was slightly higher in the testosterone group. Most of the androgenic AEs were mild and did not result in study discontinuation.

A study of 562 surgically menopausal women with HSDD, which yielded consistent results, was presented last month at a major medical meeting of obstetricians and gynecologists.

Testosterone is produced naturally in a woman's ovaries and adrenal glands and has long been linked to female sexual function. When a woman has her ovaries surgically removed, she experiences an immediate decline in testosterone. The loss of sexual desire can be associated with this testosterone drop. According to a recent study, an estimated one in three surgically menopausal women in the U.S. has low sexual desire and nearly half of these women report being distressed about it(1). Low desire is the most commonly reported type of female sexual health complaint.

In the study, the thin, transparent testosterone patch was worn on the abdomen and is designed to work by releasing a low, controlled dose of natural testosterone. There are currently no products approved by the U.S. Food and Drug Administration to treat HSDD in women.

The 24-week, randomized, double-blind, multi-center study, called INTIMATE SM 2, enrolled surgically menopausal women with HSDD who were taking oral or transdermal estrogen. Patients were on average 49 years old, in stable relationships (mean of 18 years), and had their ovaries removed an average of nine years before study entry. Patients were randomized to receive a placebo patch or the female testosterone patch designed to deliver 300 micrograms (mcg) of testosterone per day. All patches were changed twice each week.

In the study, the primary efficacy endpoint was the change in total satisfying sexual activity, as recorded in a Sexual Activity Log (SAL), at 24 weeks. The Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS) measured seven domains of sexual function (desire, arousal, orgasm, pleasure, responsiveness, concerns and self-image) and distress associated with low desire, respectively. The SAL, PFSF and PDS are all multinational, validated instruments.

This study was sponsored by Procter & Gamble Pharmaceuticals and conducted at the Baylor College of Medicine and 50 other centers in the U.S., Canada and Australia. P&G Pharmaceuticals formed a joint collaboration with Watson Pharmaceuticals, Inc., to develop the female testosterone patch.