Testosterone Improves Sexual Function in Women With Hypoactive Sexual Desire Disorder
Thursday, November 20th 2003
In oophorectomized women with hypoactive sexual desire disorder (HSDD), a testosterone patch appears to be well tolerated and improves sexual functioning, phase II trial results suggest.
Susan Davis, PhD, research director with the Jean Hailes Foundation in Clayton South, Victoria, Australia, and colleagues presented their findings in an oral presentation Wednesday at the 59th annual meeting of the American Society of Reproductive Medicine in San Antonio, Texas.
"The importance of this study was that these women were also using an estrogen patch; therefore, they produce increased levels of binding proteins, and a higher dose of testosterone may be necessary to show an effect," Dr. Davis told Medscape in a phone interview.
In a phase II study, 77 women with HSDD using concomitant transdermal estrogen therapy were enrolled in a 24-week randomized double-blind trial conducted in Europe and Australia. Patients received either testosterone 300 µg/day by transdermal patch or an identical placebo patch twice a week.
The researchers evaluated sexual satisfaction with the sexual desire domain of the Profile of Female Sexual Function (PFSF) and the frequency of satisfying sexual activity from the sexual activity log (SAL).
After 24 weeks, the women in the testosterone group showed a significant increase in the sexual desire score of the PFSF compared with those in the placebo group (16 vs. 6 units; P < .05). The increase in the testosterone group's score corresponded to a 38% increase compared with the placebo group and a mean change over baseline of 75%.
In addition, a 43% increase was observed in the frequency of total satisfying sexual activity for the testosterone group compared with the placebo group (P < .06), and mean change over baseline for the testosterone group was 110% (P < .05).
"Testosterone therapy also resulted in a statistically significant change versus placebo for each of the following PFSF domains: orgasm, sexual arousal, sexual responsiveness, sexual self-image, and sexual concerns," the authors report in their abstract. In addition, the testosterone group experienced a significant decrease in personal distress compared with the placebo group (P < .05).
Borderline positive effects were also seen for the General Health (P = 0.06) and Positive Well-Being (P = .0518) subscales of the Psychological General Well-being Index in women taking testosterone.
Blood testosterone levels correlated significantly with multiple PFSF and SAL domains. Adverse events were similar between the two groups, Dr. Davis and colleagues note.
"We saw in this study good efficacy with very little placebo effect and no increased treatment-related effects such as increased body hair or acne," Dr. Davis said. The most common adverse events reported were application site reactions, typically of most patches, she added.
Dr. Davis also noted that a study of testosterone patch use in premenopausal women was published in the September-October issue of Menopause, and it showed similar improvement in all the sexual parameters and measures of well-being in these women.
According to Dr. Davis, studies in naturally menopausal women are currently underway. "We predict the same benefit in these women as in premenopausal women," she said.
The study was funded by Proctor & Gamble Pharmaceuticals, the manufacturer of the testosterone patch.
ASRM 2003 Annual Meeting: Abstract O-199. Presented Oct. 15, 2003.
by Emma Hitt, PhD Reviewed by Gary D. Vogin, MD
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