NCT00256685已完成3 期
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 568 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 568
- 主要终点
- Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, postmenopausal women who seek treatment for hot flushes
- •Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
- •Body Mass Index (BMI) less than or equal to 40 kg/m2
- •Other inclusions apply.
排除标准
- •Hypersensitivity to Venlafaxine
- •History of seizure disorder
- •History of myocardial infarction or unstable angina within 6 months
- •Other exclusions apply.
结局指标
主要结局
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
次要结局
- Sleep, mood
研究者
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