Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women - A randomized, placebo-controlled trial
Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women - A randomized, placebo-controlled trial
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DOI：
10.1001/archinte.165.14.1582
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发表时间：
2005-07-25
影响因子：
--
通讯作者：
Watts, NB
中科院分区：
文献类型：
--
作者：
Braunstein, GD;Sundwall, DA;Watts, NB
背景：卵巢切除术降低血清睾酮水平。我们研究的有效性和安全性的睾酮透皮治疗性欲减退症手术绝经women.Methods：一个24周，随机，双盲，安慰剂对照，平行组，多中心试验进行了妇女（年龄24-70岁）谁开发的痛苦低性欲双侧输卵管卵巢切除术和子宫切除术后，谁正在接受口服雌激素治疗。女性随机接受安慰剂（n = 119）或睾酮贴片，剂量为150 μ g/d（n= 107），300 μ g/d（n= 110）或450 μ g/d（n = 111），每周两次，持续24周。性欲和频率满意的性活动是主要的疗效结局measurement.Results：447名妇女随机，318（71%）完成了试验。与安慰剂相比，接受300 μ g/d睾酮贴片的女性在性欲（67% vs 48%; P=.05）和满意性活动频率（79% vs 43%; P =.05）方面的基线增加显著。049）。150 μ g/d组未显示出治疗效果的证据。450 μ g/d组与300 μ g/d组或安慰剂组也没有统计学差异。在24周时，观察到总体满意性活动和性欲的轻微显著线性剂量反应趋势（分别为P= 0.06和0.06）。不良事件发生在两组相似的频率，没有严重的安全问题observed.Conclusions：300 μ g/d睾酮贴片增加性欲和频率满意的性活动，并在手术绝经后发展为性欲减退症的妇女耐受性良好。
Background: Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.Methods: A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 mu g/d (n= 107),300 mu g/d (n= 110), or 450 mu g/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.Results: Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-mu g/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P=.05) and in frequency of satisfying sexual activity (79% vs 43%; P =. 049). The 150-mu g/d group showed no evidence of a treatment effect. The 450-mu g/d group also was not statistically different from the 300-mu g/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P=.06 and.06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed.Conclusions: The 300-mu g/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.