NCT01607658已完成2 期
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 47
- 主要终点
- Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
研究概览
简要总结
The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.
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
- 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
Placebo
Placebo Comparator
Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
干预措施: Placebo (Drug)
Experimental 1
Experimental
Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn
干预措施: Low dose TBS-2 (Drug)
Experimental 2
Experimental
Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn
干预措施: Medium dose TBS-2 (Drug)
Experimental 3
Experimental
High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn
干预措施: High dose TBS-2 (Drug)
结局指标
主要结局
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
时间窗: 84 days
次要结局
- Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84(Day 0 and Day 84)
- Change in Global Sexual Functioning From Day 0 to Day 84(Day 0 and Day 84)
- Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)(Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84))
研究者
研究点 (47)
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