NCT00277914已完成3 期
12-month Sustained Efficacy of Flibanserin v Placebo n Younger Women With HSDD in NA
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 749
- 试验地点
- 66
- 主要终点
- Duration of efficacy of flibanserin in Sexually Satisfying Events
研究概览
简要总结
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 and pre-menopausal
- •FSDS-R above 14
- •Willingness to try to have sexual activity at least monthly
- •Willingness to use an electronic diary daily
- •Stable, monogamous, heterosexual relationship for at least one year
- •Medically acceptable method of contraception
排除标准
- •Clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial
- •Specified medications
- •Sexual function affected by medication
- •Drug dependence or abuse
- •Sexual partner needing treatment
- •Peri-Menopause or Menopause (surgical or otherwise)
- •Pelvic Inflammatory Disease
- •Major depressive Episode
- •Significant ECG abnormalities
- •Significant Neurologic findings
- •Significant GI, Hepatic, Cardiovascular, Renal, Hematologic, Immunologic or Respiratory findings
- •Uncorrected thyroid or endocrine disease
- •Uncontrolled Glaucoma
结局指标
主要结局
Duration of efficacy of flibanserin in Sexually Satisfying Events
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (66)
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