In New Study
Testosterone Patch Improved Sexual Desire in Women

Surgically Menopausal Women Reported Significant Increase in Frequency of Total Satisfying Sexual Activity

MIAMI BEACH, FL -- (MARKET WIRE) -- 09/18/2003 -- In a Phase II efficacy and safety study, treatment with a transdermal testosterone patch significantly increased sexual desire and sexual activity in women with Hypoactive Sexual Desire Disorder (HSDD) resulting from the surgical removal of both ovaries. The findings of the study were presented today at the 14th Annual Meeting of The North American Menopause Society (NAMS).

"While we know that sexual functioning in women is incredibly complex, these positive results add to the growing evidence that testosterone plays a very important role in women's sexual desire," said Glenn Braunstein, M.D., lead study investigator and Chair of the Department of Medicine at Cedars-Sinai Medical Center in Los Angeles. "With no medications currently approved by the U.S. Food and Drug Administration for the treatment of diminished sexual desire in women, we're very excited about the promise the testosterone patch shows. We hope further trials like this will lead to approved medical treatments to help women with low desire regain a satisfying sex life."

HSDD is common in surgically menopausal women. 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) HSDD is characterized by a lack of sexual desire, including persistent or recurring deficiency or absence of sexual fantasies or thoughts, or a lack of interest in sex, which causes a woman personal distress. Growing evidence suggests that sufficient levels of testosterone, produced naturally in the ovaries and adrenal glands, are instrumental for proper sexual functioning. Consequently, when ovaries are removed, HSDD can result.(2, 3)

This study was sponsored by Procter and Gamble Pharmaceuticals and conducted at Cedars-Sinai and other centers in the U.S.

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ABOUT THE STUDY

The 24-week, randomized, double-blind, multi-center study consisted of 447 surgically menopausal women receiving oral estrogen who reported low sexual desire that caused distress. Patients were randomized to receive a placebo patch or a transdermal testosterone patch designed to deliver 150, 300 or 450 micrograms (µg) of testosterone per day. All patches were changed twice weekly. The primary efficacy endpoints of the study were the frequency of satisfying sexual activity, as recorded in a Sexual Activity Log (SAL), and the sexual desire domain of the Profile of Female Sexual Function (PFSF), a multinational, validated instrument that measures seven domains of sexual function (desire, arousal, orgasm, pleasure, responsiveness, concerns and self-image). The primary comparisons tested for the presence of a linear dose response, and secondary comparisons were made between all testosterone doses and placebo.

STUDY RESULTS

Results show the group treated with the 300 µg/day testosterone patch experienced a 30 percent increase in the frequency of total satisfying sexual activity vs. placebo (p less than 0.05 ), and an 81 percent increase vs. baseline (p less than 0.05 ) at 24 weeks. The 150 µg/day group was similar to placebo, and there was no advantage of the 450 µg/day group over the 300 µg/day group.

The 300 µg/day group also experienced a 66 percent increase in sexual desire vs. baseline (p less than 0.05 ) and a significant increase vs. placebo (p less than 0.05 ). A positive trend (p = 0.0970) was seen for the 450 µg/day group, and no significant differences were observed for the 150 µg/day group (p = 0.3540). Marginally significant dose effects were observed for total satisfying sexual activity and sexual desire at 24 weeks, p = 0.062 and 0.059, respectively. Dose-related increases in mean concentrations of free, total and bioavailable testosterone were observed, and androgen concentrations significantly correlated with multiple PFSF and SAL domains.

Overall, adverse events (AE) reports were similar in the placebo and testosterone groups. The most common AEs reported were application site reactions, infection, acne and headache.