Testosterone Patch Increases Sexual Function in Women

Peggy Peck

May 06, 2004

May 6, 2004 (Philadelphia) — In surgically menopausal women with hypoactive sexual desire disorder (HSDD), treatment with an investigational transdermal patch was associated with significant increases in sexual desire and sexual activity with no serious adverse effects, according to findings reported here at the 52nd annual clinical meeting of the American College of Obstetricians and Gynecologists.

Lead investigator James Simon, MD, a clinical professor of obstetrics and gynecology at George Washington University in Washington, D.C., told Medscape that the trial is the "first large, prospective, randomized trial to demonstrate that physiologic levels of testosterone improve sexual functioning in surgically menopausal women."

Dr. Simon, who is president-elect of the North American Menopause Society, said a similar trial in naturally menopausal women is just now completing data collection. He declined to comment on the preliminary findings in that study but said the results are expected to be reported in the fall.

About 30% to 50% of women who undergo hysterectomy report decreased sexual desire and about half of women who undergo bilateral oopherectomy report a decrease in sexual function, Dr. Simon said.

The 24-week study randomized women who had undergone hysterectomy and bilateral oopherectomy at least six months before to 300 µg testosterone administered by testosterone transdermal patch (TTP) twice a week or placebo. The primary end point was change in total sexual activity as recorded in a sexual activity log (SAL). A secondary end point was score on the Profile of Female Sexual Function (PFSF), an instrument that records seven domains of sexual function, including number of sexual activities, both intercourse and nonintercourse, and orgasm. Incidence of personal distress disorder (PDD) was also evaluated.

The mean age of the women was 49 years, and all women were in stable relationships (mean length, 19 years). Of the total 562 women enrolled, 283 were randomized to TTP and 279 to placebo.

At 24 weeks, SAL scores of women in the TTP group increased by 74% compared with a 33% increase in the placebo group (P = .003). Women in the TTP group reported a 56% increase in sexual desire from baseline and also reported increases in all seven PFSF domains, including arousal, orgasm, pleasure, responsiveness, and self-image. Moreover, the patch was well tolerated, with 2.5% of women reporting any adverse events.

Gerard Nahum, MD, FACOG, associate professor at Duke University in Durham, North Carolina, told Medscape the study is interesting, but "this is a really select population with a remote history of surgery." The average time since surgery was nine years. "So, I'm concerned that this is quite a limited subset of women."

Aside from the caveat, Dr. Nahum, who was not involved in the study, but is a member of the ACOG program committee, said, "The results are nice and do demonstrate a statistically significant effect, so this obviously warrants further study."

ACOG 52nd Annual Clinical Meeting: Poster 30. Presented May 4, 2004.

Reviewed by Gary D. Vogin, MD