NCT04943068已完成3 期
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
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
- 193
- 试验地点
- 1
- 主要终点
- Change from baseline to End of Study in the desire domain from the FSFI
研究概览
简要总结
The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).
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
- 19 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
Bremelanotide
Experimental
Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period
干预措施: Bremelanotide (Drug)
Placebo
Placebo Comparator
Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to End of Study in the desire domain from the FSFI
时间窗: Baseline up to End of Study(8weeks)
次要结局
- Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.(Baseline up to End of Study(8weeks))
- Change from Baseline to End of study in the scored time spent being concerned by difficulty with sexual arousal as measured by the FSDS-DAO Q14.(Baseline up to End of Study(8weeks))
- Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.(Baseline up to End of Study(8weeks))
- Change from Baseline to End of study in the total number of SSEs.(Baseline up to End of Study(8weeks))
- Change from baseline to End of Study in FSDS-DAO (Item 13)(Baseline up to End of Study(8weeks))
- Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration(Baseline up to End of Study(8weeks))
- Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R(Baseline up to End of Study(8weeks))
- Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R(Baseline up to End of Study(8weeks))
- Change from Baseline to End of Study in the FSDS-DAO Total Score(Baseline up to End of Study(8weeks))
- Change from Baseline to End of study in the total FSFI score based on the 19 questions(Baseline up to End of Study(8weeks))
- Change in mean Level of Sexual Arousal from FSEP-R Q6(Baseline up to End of Study(8weeks))
- Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5)(Baseline up to End of Study(8weeks))
- Change from baseline in the score for feeling bothered by low sexual desire as measured by the FSDS -DAO Q13 using all available double-blind data(visit 4, 5)(Baseline up to End of Study(8weeks))
- Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.(Baseline up to End of Study(8weeks))
研究者
研究点 (1)
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