A Phase 2b, Multi-Center, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients With Female Sexual Arousal Disorder (FSAD)
试验速览
- 阶段
- 2 期
- 入组人数
- 440
- 试验地点
- 51
- 主要终点
- SFQ28 (AS) - 28 Day Recall
研究概览
简要总结
This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil locally to the vulvar-vaginal tissue.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sildenafil Cream, 3.6%
干预措施: Sildenafil (Drug)
Placebo Cream
干预措施: Placebo (Drug)
结局指标
主要结局
SFQ28 (AS) - 28 Day Recall
时间窗: SFQ28 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.
Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the Arousal-Sensation Domain of the SFQ28.
FSDS-DAO (Q14) - 28 Day Recall
时间窗: Q14 score at the end of the Single-Blind Placebo Run-In to the end of the 12-Week Double-blind Dosing period.
Evaluating the efficacy of Sildenafil Cream, 3.6% measured by change from baseline to end of study in the score for feeling concerned by difficulties with sexual arousal - Item #14 only of the FSDS-DAO.
次要结局
- Arousal Diary (SSE)(measured by daily prompt within 24hrs after each sexual event during the Single-Blind Placebo Run-In compared to the last 4 weeks of the Double-Blind Dosing Period.)