Hudson Valley Urology, Poughkeepsie, New York, NY 12601, USA.
J Sex Med. 2011 Nov;8(11):3160-72. doi: 10.1111/j.1743-6109.2011.02458.x. Epub 2011 Sep 20.
Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD).
To assess the efficacy and safety of flibanserin over 24 weeks of double-blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open-label treatment with flibanserin.
Women (N = 738) were treated with open-label, flexible-dose flibanserin (50 mg or 100 mg/day) for 24 weeks. At week 24, women who showed a predefined response, measured using an eDiary, were randomized to 24 weeks of continued flibanserin therapy at optimized dosage (N = 163) or placebo (N = 170). The criteria for entering the double-blind phase were an increase from baseline to weeks 21-24 of ≥2 satisfying sexual events (SSE) and/or ≥4 "desire days." A "desire day" was one in which a woman reported more than "no" desire.
Coprimary endpoints were change from randomization to study end in SSE and desire score. Secondary measures included change in Female Sexual Function Index (FSFI) total and desire domain scores and Female Sexual Distress Scale-Revised (FSDS-R) total and Item 13 scores.
During the open-label period, mean SSE and desire score approximately doubled, and FSFI, FSDS-R total, and Item 13 scores improved. At the end of the double-blind period, flibanserin was superior to placebo in change from randomization in SSE, desire score, FSFI desire domain and total scores, and FSDS-R total and Item 13 scores (P < 0.05, for all). Flibanserin was well tolerated, and withdrawal reactions were not observed.
At the end of the 24-week randomized withdrawal phase of a 48-week trial in premenopausal women with HSDD, flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress. Flibanserin was well tolerated, and no withdrawal reactions were observed following discontinuation.
氟班色林是一种 5-HT（1A）激动剂/5-HT（2A）拮抗剂，已被证明可增加绝经前患有低性欲障碍（HSDD）女性的性欲并减轻其痛苦。
评估氟班色林在 24 周双盲治疗与安慰剂相比在接受氟班色林 24 周开放性治疗后表现出预定义反应的 HSDD 绝经前妇女中的疗效和安全性。
共 738 名女性接受了开放性、剂量灵活的氟班色林（50 毫克或 100 毫克/天）治疗 24 周。在第 24 周，使用电子日记测量到表现出预定义反应的女性被随机分配至 24 周的优化剂量氟班色林治疗（n=163）或安慰剂（n=170）。进入双盲阶段的标准为从基线到第 21-24 周时增加≥2 次满足性事件（SSE）和/或≥4 个“欲望日”。“欲望日”是指女性报告的欲望多于“无”的日子。
主要终点为从随机分组到研究结束时 SSE 和欲望评分的变化。次要指标包括女性性功能指数（FSFI）总分和欲望域评分以及女性性困扰量表修订版（FSDS-R）总分和第 13 项评分的变化。
在开放性治疗期间，SSE 和欲望评分平均增加了近一倍，FSFI、FSDS-R 总分和第 13 项评分也有所改善。在双盲治疗期末，氟班色林在 SSE、欲望评分、FSFI 欲望域和总分以及 FSDS-R 总分和第 13 项评分的变化方面优于安慰剂（P<0.05，均为）。氟班色林耐受良好，未观察到停药反应。
在 HSDD 绝经前女性为期 48 周的随机撤药 24 周试验的撤药阶段结束时，氟班色林在 SSE、性欲、总体性功能和性困扰方面优于安慰剂。氟班色林耐受良好，停药后未观察到停药反应。
