Kingsberg Sheryl, Shifren Jan, Wekselman Kathryn, Rodenberg Cynthia, Koochaki Patricia, Derogatis Leonard
University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
J Sex Med. 2007 Jul;4(4 Pt 1):1001-8. doi: 10.1111/j.1743-6109.2007.00526.x.
Postmenopausal 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.
To evaluate the clinical relevance of the treatment benefits.
This 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.
Women 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.
Overall, 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).
Surgically menopausal women with HSDD in these studies received clinically meaningful benefits, including improvements in satisfying sexual activity, sexual desire, and personal distress.
在III期试验中，患有性欲减退障碍（HSDD）的绝经后女性在接受睾酮治疗后，在性活动满意度、性欲和困扰方面的频率有统计学上的显著改善，但尚不清楚这些影响的程度在临床上是否有意义。本临床相关性研究旨在回答这个问题。
评估治疗益处的临床相关性。
本研究纳入了132名接受手术绝经且患有HSDD的女性，她们来自两项随机、安慰剂对照试验（N = 1094），评估了经皮睾酮治疗（300微克/天）6个月的疗效和安全性。在研究结束时，在揭盲前，对一部分女性（12%）进行了关于她们治疗体验的访谈。
询问女性“总体而言，你会说你从研究贴片治疗中获得了有意义的益处吗？”对在双盲研究中体验到和未体验到总体有意义益处的女性，比较其疗效终点的变化。
总体而言，接受睾酮治疗的64名女性中有33名（52%）报告体验到了有意义的治疗益处，而接受安慰剂治疗的68名女性中有21名（31%）（P = 0.025）。在那些认为自己体验到有意义益处的女性中，从基线开始，每4周性活动满意度的平均（标准误）变化为4.4（0.76），性欲评分变化为21.0（2.78），从“很少”有性欲变为“有时”有性欲，困扰评分变化为-36.5（3.96），从“经常”困扰变为“很少”困扰。在那些认为自己未体验到有意义益处的女性中，从基线开始，每4周性活动满意度的平均（标准误）变化为0.5（0.31），性欲评分变化为2.9（1.42），困扰评分变化为-8.8（2.23）。
在这些研究中，患有HSDD的手术绝经女性获得了临床上有意义的益处，包括性活动满意度、性欲和个人困扰方面的改善。
