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Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET Study

机译:绝经前妇女性欲减退的治疗:氟班色林在紫罗兰研究中的功效

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Introduction. Hypoactive Sexual Desire Disorder (HSDD) is the most common form of Female Sexual Dysfunction and is characterized by low sexual desire that causes distress. Aim. The aim of this study was to assess the efficacy and safety of flibanserin, a postsynaptic 5-HT 1A agonist/5-HT 2A antagonist, in premenopausal women with HSDD. Methods. North American premenopausal women with HSDD were randomized to 24 weeks' treatment with placebo (N=295), flibanserin 50mg (N=295), or flibanserin 100mg (N=290), once daily at bedtime. Main Outcome Measures. Coprimary endpoints were change from baseline to study end in number of satisfying sexual events (SSE) and sexual desire score measured daily using an electronic diary (eDiary). Secondary endpoints included change from baseline to study end in Female Sexual Function Index (FSFI) desire domain and total scores, Female Sexual Distress Scale-Revised (FSDS-R) Item 13 and total scores, and Patient's Global Impression of Improvement. Results. Flibanserin 50mg and 100mg led to increases in SSE (P0.05 and P0.01 vs. placebo, respectively). There was a numerical trend toward improvement in eDiary desire score on flibanserin 100mg, but statistical significance was not reached (P=0.07 vs. placebo). FSFI desire domain and total scores increased with both flibanserin regimens (P0.05). FSDS-R total and Item 13 scores decreased with flibanserin 100mg (P0.001), indicating reduced sexual distress. More women receiving flibanserin 50mg and 100mg considered their HSDD to have improved than women receiving placebo (39.6% and 50.0% vs. 30.3%, respectively) (P0.05). Conclusion. In premenopausal women with HSDD, flibanserin 50mg and 100mg once daily at bedtime were well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score) and overall sexual function, and reduction of sexual distress, vs. placebo.
机译:介绍。性欲减退(HSDD)是女性性功能障碍最常见的形式,其特征是性欲低下,会导致困扰。目标。这项研究的目的是评估氟班色林(一种突触后5-HT 1A激动剂/ 5-HT 2A拮抗剂)对HSDD绝经前妇女的疗效和安全性。方法。北美HSSD绝经前女性被随机分配到24周的安慰剂治疗(N = 295),氟班色林50mg(N = 295)或氟班色林100mg(N = 290),每天睡前一次。主要观察指标。共有主要终点从基线到研究结束时,通过电子日记(eDiary)每天测量的令人满意的性事件(SSE)和性欲得分的变化。次要终点包括从基线到研究结束时女性性功能指数(FSFI)期望域和总分的变化,女性性窘迫量表修订(FSDS-R)项目13和总分,以及患者的整体改善印象。结果。氟班色林50mg和100mg导致SSE升高(与安慰剂相比分别为P <0.05和P <0.01)。氟班色林100mg的eDiary欲望评分有改善的数字趋势,但未达到统计学显着性(与安慰剂相比P = 0.07)。两种氟班色林方案的FSFI欲望域和总分均升高(P <0.05)。氟班色林100mg的FSDS-R总分和项目13得分降低(P <0.001),表明性苦恼减少。接受氟班色林50mg和100mg的女性认为其HSDD较接受安慰剂的女性有所改善(分别为39.6%和50.0%对30.3%)(P <0.05)。结论。在绝经前的HSDD患者中,每天睡前一次服用氟班色林50mg和100mg的氟班色林耐受性良好,并且与SSE,性欲(FSFI欲望域评分但不包括eDiary欲望评分)和总体性功能的统计显着改善相关,并减少了性苦恼,与安慰剂。

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