NCT01103362终止3 期
Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 596
- 试验地点
- 95
- 主要终点
- The Frequency of Adverse Events
研究概览
简要总结
To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
Experimental
flibanserin 100mg po qd
干预措施: flibanserin (Drug)
结局指标
主要结局
The Frequency of Adverse Events
时间窗: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD
次要结局
未报告次要终点
研究者
研究点 (95)
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