24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 949
- 试验地点
- 75
- 主要终点
- Change From Baseline in the Number of Satisfying Sexual Events
研究概览
简要总结
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
flibanserin 100mg
flibanserin 100mg po qd
干预措施: flibanserin (Drug)
placebo
placebo one tablet po qd
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in the Number of Satisfying Sexual Events
时间窗: baseline through 24 weeks
A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
时间窗: baseline through 24 weeks
The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).
次要结局
- Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)(change from baseline to 24 weeks)
