NCT00613002已完成3 期
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
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
- 597
- 试验地点
- 63
- 主要终点
- Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel® 300mcg in the treatment of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be between the ages of 30 to 65 years
- •Must have undergone hysterectomy and bilateral salpingo-oophorectomy
排除标准
- •A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
- •Any systemic skin diseases or local skin abnormalities in the area of application
- •Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
- •A medical condition that could affect or interfere with sexual function
- •Using a systemic topical gel or cream estrogen therapy.
研究组 & 干预措施
testosterone gel
Experimental
1% testosterone transdermal gel
干预措施: testosterone gel (Drug)
placebo gel
Placebo Comparator
placebo transdermal gel
干预措施: placebo gel (Drug)
结局指标
主要结局
Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.
时间窗: Baseline and 21-24 weeks.
次要结局
- Change from baseline over time for multiple efficacy measurements(change over timepoints from baseline)
研究者
研究点 (63)
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