跳至主要内容
临床试验/NCT00996372
NCT00996372已完成3 期

24-wk Efficacy and Safety of Flibanserin vs Pbo in Naturally Postmenopausal Women in United States

Sprout Pharmaceuticals, Inc75 个研究点 分布在 1 个国家目标入组 949 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

flibanserin 100mg

Experimental

flibanserin 100mg po qd

干预措施: flibanserin (Drug)

placebo

Placebo Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (75)

Loading locations...

相似试验

Flibanserin for the Treatment of Hypoactive Sexual... | 临床试验