• Sheryl Kingsberg, Jan Shifren, Kathryn Wekselman, Cynthia Rodenberg, Patricia Koochaki, and Leonard Derogatis.
• University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA. Sheryl.Kingsberg@UHhospitals.org
• J Sex Med. 2007 Jul 1; 4 (4 Pt 1): 1001-8.

IntroductionPostmenopausal women with hypoactive sexual desire disorder (HSDD) experienced statistically significant improvements in the frequency of satisfying sexual activity, sexual desire, and distress with testosterone treatment in phase III trials, but it was not known whether the magnitude of these effects was clinically meaningful. The clinical relevance study was designed to answer this question.AimTo evaluate the clinical relevance of the treatment benefits.MethodsThis study involved a representative sample of 132 surgically postmenopausal women with HSDD who were enrolled in two randomized, placebo-controlled trials (N = 1094) assessing the efficacy and safety of transdermal testosterone treatment (300 mcg/day) for 6 months. At the end of the studies, prior to unblinding, a sample of women (12%) was interviewed concerning their experiences with the treatment.Main Outcome MeasuresWomen were asked "Overall, would you say that you experienced a meaningful benefit from the study patches?" Changes in the efficacy end points in the double-blind studies were compared for the women who did and did not experience an overall meaningful benefit.ResultsOverall, 33 of 64 women (52%) who received testosterone reported experiencing a meaningful treatment benefit, compared with 21 of 68 women (31%) who received placebo (P = 0.025). Among the women who identified themselves as experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 4.4 (0.76), in desire score was 21.0 (2.78), moving from "seldom" to "sometimes" feeling sexual desire, and in distress score was -36.5 (3.96), moving from "often" to "seldom" being distressed. Among the women who identified themselves as not experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 0.5 (0.31), in desire score was 2.9 (1.42), and in distress score was -8.8 (2.23).ConclusionsSurgically menopausal women with HSDD in these studies received clinically meaningful benefits, including improvements in satisfying sexual activity, sexual desire, and personal distress.

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