NCT03287232已完成3 期
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)
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
- 653
- 试验地点
- 69
- 主要终点
- Sexual desire
研究概览
简要总结
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（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
Placebo
Placebo Comparator
干预措施: Placebo Vaginal Insert (Drug)
Prasterone
Experimental
干预措施: Prasterone 6.5 mg (0.50%) Vaginal Insert (Drug)
结局指标
主要结局
Sexual desire
时间窗: 28 weeks
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Distress from low sexual desire
时间窗: 28 weeks
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
次要结局
- Satisfying sexual events (SSEs)(28 weeks)
研究者
研究点 (69)
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