MONDAY, July 25, 2005 (HealthDay News) -- A testosterone patch worn on the skin improves sexual desire and sexual satisfaction in women who have had their ovaries removed, a new study says.
The finding is unlikely to change a decision made last December by the U.S. Food and Drug Administration to nix the patch, known as Intrinsa, due to insufficient long-term safety data. The initial results of this study were first presented to the agency last fall as part of that unsuccessful approval process.
"The FDA has already reviewed this data," said Dr. Glenn D. Braunstein, lead author of the study, which appears in the July 25 issue of the Archives of Internal Medicine. "The FDA basically said that they agreed that the patch was efficacious, but wanted longer-term safety data."
According to Braunstein, who is chairman of the department of medicine at Cedars-Sinai Medical Center in Los Angeles, the FDA and Procter & Gamble, which makes the patch, are "having conversations as to what would be an appropriate long-term study." Braunstein is a consultant for the company, which also funded this study.
Some 30 percent to 50 percent of women who undergo so-called "surgical menopause" report diminished sexual desire. As a result of this procedure, blood levels of different sex hormones, including testosterone, go down about 50 percent. For some women, estrogen can fix the situation. Other women, however, seem to need estrogen and testosterone.
Thus far, the only remedies available to women for low libido are off-label, including Estratest (estrogen and methyltestosterone), currently on the market for relief of menopausal symptoms, and some other products that are specifically made for men.
This study looked at 447 women aged 24 to 70 who were experiencing hypoactive sexual desire disorder -- chronic lack of desire resulting in personal distress. The women, all of whom had undergone surgical menopause and were taking oral estrogen, were randomized to receive either placebo or testosterone patches twice weekly in one of three progressively higher doses.
All participants answered questionnaires and filled out a sexual function activity log.
Women receiving the intermediate dosage (300 micrograms daily) reported greater increases in sexual desire (67 percent) than women taking a placebo (48 percent). They also reported more satisfaction (79 percent vs. 43 percent) than the placebo group).
Women taking the lowest dosage (150 micrograms per day) showed no evidence of an effect. Those in the highest-dose group (450 micrograms) had increases in sexual desire but were no different from the placebo group when rating sexual satisfaction.
According to an accompanying editorial, the study does not definitively identify the "right" dose of testosterone for this group of women. Editorialist Dr. Robert Vigersky, of Walter Reed Army Medical Center, Washington, D.C., noted that treatment only brought about "modest" improvements: Women's self-reported level of sexual function went from "seldom" to just "sometimes," while frequency of satisfying sexual activity rose from three episodes per month to five.
The authors also noted the strong placebo response in the study, something potentially attributed to increased dialogue between participants and their partners brought on by participating in the study.
The treatment also produced side effects in some women, including acne and hair growth.
These results will not change the prospects for the patch, which are still very much up in the air.
"Because of the WHI [Women's Health Initiative] study, there's concern about steroid hormones in general and potential long-term side effects, etcetera, etcetera," Braunstein said. "This is also a quality-of-life drug, not a life-or-death drug. My gestalt is that it's being held to a little bit higher standard. Because of that, and because of the issues around Vioxx, I think the FDA took a very, very conservative approach. I'm hopeful they will eventually approve this, [but] what's going to happen is 'I don't know.'"
More information
The American Association of Marriage and Family Therapy has more on female sexual dysfunction.
