NCT00727129已完成3 期
Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 主要终点
- Daily frequency and severity of moderate to severe vasomotor symptoms
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Have moderate to severe hot flashes
- •Normal Pap Smear
排除标准
- •Abnormal mammogram
- •Abnormal clinical breast exam
结局指标
主要结局
Daily frequency and severity of moderate to severe vasomotor symptoms
次要结局
- vulvar and vaginal atrophy
研究者
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