NCT00441558终止3 期
Worldwide One-year Open-label Safety Study of Flibanserin in Women With HSDD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,723
- 试验地点
- 196
- 主要终点
- The Frequency of Adverse Events (Side Effects).
研究概览
简要总结
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
- •Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
- •Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
- •Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.
排除标准
- •A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
- •Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
- •Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
- •Patients who are pregnant or have been pregnant within 1 month prior to study start.
- •Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
- •Clinically significant ECG or lab abnormalities at study start.
- •Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
研究组 & 干预措施
flibanserin
Experimental
flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
干预措施: Flibanserin (Drug)
结局指标
主要结局
The Frequency of Adverse Events (Side Effects).
时间窗: 52 weeks
This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder
次要结局
未报告次要终点
研究者
研究点 (196)
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