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首页> 外文期刊>The journal of sexual medicine >Satisfying sexual events as outcome measures in clinical trial of female sexual dysfunction.
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Satisfying sexual events as outcome measures in clinical trial of female sexual dysfunction.

机译：在女性性功能障碍的临床试验中，满足性事件作为结果指标。

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INTRODUCTION: Assessing the sexual response in women with female sexual dysfunctions (FSDs) in clinical trials remains difficult. Part of the challenge is the development of meaningful and valid end points that capture the complexity of women's sexual response. AIM: The purpose of this review is to highlight the shortcomings of daily diaries and the limitations of satisfying sexual events (SSEs) as primary end points in clinical trials of women with hypoactive sexual desire disorder (HSDD) as recommended by the Food and Drug Administration (FDA) in their draft guidance on standards for clinical trials in women with FSD. METHODS: Clinical trials in women with HSDD using SSEs as primary end points were reviewed. MAIN OUTCOME MEASURES: The agreement between three outcome measures (SSEs, desire, and distress) was assessed to illustrate to what degree improvements in SSEs were in agreement with improvements in sexual desire and/or personal distress. RESULTS: Nine placebo-controlled randomized trials in women with HSDD were reviewed: seven with transdermal testosterone and two with flibanserin. In four trials, all using transdermal testosterone 300 microg/day had agreement between changes in SSEs, desire, and distress. In five studies (testosterone 300 microg/day, n = 2; testosterone 150 microg/day, n = 1; flibanserin n = 2), changes in SSEs did not correlate with changes in desire and/or distress and vice versa. It should be noted that in the flibanserin trials, SSEs did correlate with desire assessed using the Female Sexual Function Index but not when it was assessed using the eDiary. CONCLUSIONS: Findings in the literature do not uniformly support the recommendations from the FDA draft guidance to use diary measures in clinical trials of HSDD as primary end points. Patient-reported outcomes appear to be better suited to capture the multidimensional and more subjective information collected in trials of FSD.
机译：简介：在临床试验中评估具有女性性功能障碍（FSD）的女性的性反应仍然很困难。挑战的一部分是发展有意义的有效终点，以捕捉女性性反应的复杂性。目的：本次审查的目的是强调食品和药物管理局建议的性欲减退妇女（HSDD）临床试验的主要终点是每日日记的缺点和满足性事件（SSE）的局限性（FDA）在有关FSD妇女临床试验标准的指南草案中。方法：回顾了以SSEs为主要终点的HSDD妇女的临床试验。主要观察指标：评估了三种结果指标（SSE，欲望和痛苦）之间的一致性，以说明SSE的改善与性欲和/或个人困扰的改善在多大程度上相符。结果：回顾了9例HSDD妇女的安慰剂对照随机试验：7例经皮睾丸激素治疗和2例氟班色林治疗。在四项试验中，所有每天使用300微克透皮睾丸激素的患者，其SSE，性欲和痛苦的变化之间存在一致性。在五项研究中（睾丸激素300微克/天，n = 2;睾丸激素150微克/天，n = 1;氟班色林n = 2），SSE的变化与欲望和/或痛苦的变化不相关，反之亦然。应该注意的是，在氟班色林试验中，SSE确实与使用女性性功能指数评估的性欲相关，但在使用eDiary进行评估时却不相关。结论：文献中的发现并不一致地支持FDA指南草案的建议，即在HSDD的临床试验中使用日记测量作为主要终点。患者报告的结果似乎更适合捕获FSD试验中收集的多维信息和更主观的信息。

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