NCT00482664已完成2 期
A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
研究概览
简要总结
CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy pre-menopausal women
- •primary female sexual arousal disorder causing distress
- •on stable use of oral contraceptives
排除标准
- •any other significant disease causing Female Sexual Dysfunction including psychiatric disease
- •subjects on drugs known to cause Female Sexual Dysfunction
- •subjects who have given birth in the last 12 months or who are planning to become pregnant during the study
研究组 & 干预措施
3 mg
Experimental
干预措施: CP-866,087 (Drug)
1 mg
Experimental
干预措施: CP-866,087 (Drug)
10 mg
Experimental
干预措施: CP-866,087 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
时间窗: 6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
时间窗: 6 weeks
次要结局
- Exit interview at end of study. Meaningful Benefit Question at end of study.(End of study)
- Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.(6 weeks)
研究者
研究点 (1)
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