Testosterone Patch Can Improve Sexual Function in Women

Yael Waknine

October 11, 2004

Oct. 11, 2004 --Testosterone transdermal patch (TTP) therapy is well tolerated and significantly increases sexual activity and desire while decreasing personal distress in naturally menopausal (NM) and surgically menopausal women with hypoactive sexual desire disorder (HSDD), according to the results of two randomized, double-blind, multicenter, phase 3 trials presented at the North American Menopause Society 15th annual meeting in Washington, D.C.

"HSDD is a medical condition for women that is specifically defined as decreased desire associated with personal distress," lead investigator Jan Shifren, MD, told Medscape in a telephone interview. She is director of the menopause program of the Vincent OB-GYN Service at Massachusetts General Hospital and an assistant professor at Harvard Medical School in Boston.

Dr. Shifren and colleagues evaluated the effects of TTP therapy by randomizing 549 estrogen-treated NM women with HSDD to receive 300 µg TTP twice weekly or placebo for a period of 24 weeks. Desire and distress were assessed using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS), respectively.

"We did our initial analysis on women with typical levels of sex-hormone binding globulin (SHBG) [160 nmol/L or lower] and we didn't include the 10% of women with high levels of SHBG," said Dr. Shifren. "But then we analyzed the entire intent-to-treat (ITT) population and the good news is that the data were exactly the same for all women."

Results at 24 weeks showed that TTP therapy significantly increased the frequency of "totally satisfying" sexual episodes compared with placebo (high SHBG level group: 2.1 vs 0.5 episodes/month, P < .0001; ITT group: 1.9 vs 0.5 episodes/month, P < .0001) and compared with baseline (73% change).

In the ITT population, treatment with TTP also significantly increased desire (mean Δ PFSF scores from baseline, 9.8 vs 4.0 [Δ 48% vs 20%]; P = .0001) and decreased distress (mean Δ PDS scores from baseline, -20.5 vs &-11.5 [&#8710; -52% vs &-28%; P < .0001) compared with placebo. Results were similar in the high SHBG level group.

TTP therapy was well tolerated. "The only adverse events we saw that were slightly more likely in testosterone-treated women were slight increases in acne and facial hair," Dr. Shifren noted, adding, "These were very mild and did not cause any of the testosterone-treated women to leave the study.

"We saw statistically significant improvement in our primary end point for the study, which was the amount of totally satisfying sexual activity at 24 weeks, in testosterone-treated women as compared to placebo-treated women," said Dr. Shifren.

"It's really a very exciting study; it's truly the first time that transdermal testosterone has been shown to significantly increase sexual function in NM women in a large controlled trial," Dr. Shifren pointed out. "Very importantly, since the diagnosis of HSDD is only made in women who have decreased desire associated with distress, distress significantly decreased."

In a separate study, investigators evaluated the effects of TTP therapy compared with placebo in 562 estrogen-treated and surgically menopausal women with HSDD.

"The study we did involved hysterectomized women with [resulting] low testosterone levels," lead investigator Lila Nachtigall, MD, told Medscape in a phone interview. She is a reproductive endocrinologist and professor of obstetrics and gynecology at New York University School of Medicine in New York City.

"Women included in the study not only had a lack of desire, they were distressed over it.... These were women in a long-term relationship [mean, 18 years] who knew what it was like to have a good libido, had had one before, and they missed it terribly," Dr. Nachtigall said.

The women (mean age, 49 years; mean time since oophorectomy, 8.5 years) were randomized to receive 300 &#181;g TTP twice weekly or placebo for 24 weeks. Desire and distress were assessed using PFSF and PDS scores at baseline and at weeks 4, 8, 12, and 24. TTP therapy was well tolerated and no androgen-related adverse events were reported.

Results showed that TTP therapy significantly increased frequency of totally satisfying sexual activity compared with placebo, beginning at weeks 5 through 8 and continuing through weeks 21 to 24. Significant improvements in desire from baseline PFSF values were likewise observed with TTP therapy at weeks 4, 12, and 24 compared with placebo. Personal distress was found to decrease significantly from baseline PDS scores at weeks 4, 8, 12, and 24.

"The interesting thing...was that everything became significant early; the arousal, the return of desire, the number of satisfactory sexual encounters that they had, and the decrease in distress could all be seen at four weeks and -- and this really amazed me -- an increase in self-image as well," Dr. Nachtigall said.

Maximal effect was seen at eight to 12 weeks and was maintained through week 24, at which time treatment with TTP had resulted in a 74% increase in frequency of totally satisfying sexual activity, a 56% increase in sexual desire, and a 65% decrease in personal distress compared with placebo.

Dr. Nachtigall noted the clinical advantages of being able to tell patients to expect improvements in four weeks that will peak soon after and then remain stable over a six-month period. "This is a whole change in lifestyle," she pointed out. "I think four weeks is excellent."

Based on the results of these and other studies, Dr. Nachtigall anticipates U.S. Food and Drug Administration approval of TTP therapy for women with HSDD. "Once it's approved, it will be a very useful part of the armamentarium," she suggested. "There's a lot more distress over decreased libido than we knew."

Both studies received support from Procter & Gamble.

NAMS 15th Annual Meeting: Abstracts S-3 and S-11. Presented Oct. 8, 2004.

Reviewed by Gary D. Vogin, MD

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