Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 39
- 主要终点
- The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
研究概览
简要总结
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.
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
- 18 Years 至 50 Years（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
flibanserin 50 mg to 100 mg qhs
Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
干预措施: flibanserin 50 mg to 100 mg qhs (Drug)
flibanserin 100 mg qhs
Patient to receive 2 flibanserin tablets of 50 mg qhs
干预措施: flibanserin 100 mg qhs (Drug)
placebo 2 tablets qhs
Patient to receive 2 placebo tablets of 50 mg qhs
干预措施: placebo 2 tablets qhs (Drug)
结局指标
主要结局
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
时间窗: 17 weeks
次要结局
- The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)(12 weeks)
- The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)(12 weeks)