NCT00369434已完成3 期
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause
Wyeth is now a wholly owned subsidiary of Pfizer34 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2006年6月1日最近更新:
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相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 34
- 主要终点
- The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.
详细描述
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy, postmenopausal women who seek treatment for hot flushes
- •Body Mass Index (BMI) less than or equal to 40 kg/m2
- •Other inclusions apply.
排除标准
- •Hypersensitivity to Venlafaxine
- •Myocardial infarction and/or unstable angina within 6 months of screening
- •History of seizure disorder
- •Other exclusions apply.
结局指标
主要结局
The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.
次要结局
- The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).
- The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).
研究者
研究点 (34)
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