A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 102
- 主要终点
- Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
研究概览
简要总结
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal 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
- 30 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial
排除标准
- •Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator
研究组 & 干预措施
placebo gel
placebo transdermal gel
干预措施: placebo gel (Drug)
testosterone gel
transdermal testosterone gel
干预措施: transdermal testosterone gel 1% (Drug)
结局指标
主要结局
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
时间窗: 12 weeks
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
次要结局
- change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study(12 weeks)
- change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study(12 weeks)