NCT00108849已完成3 期
A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 58
- 主要终点
- Clinical symptoms
研究概览
简要总结
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women whose last menstruation was at least two years previously
排除标准
- 未提供
结局指标
主要结局
Clinical symptoms
时间窗: after 12 months
次要结局
- Objective parameters (vaginal Maturation Index/Value and vaginal pH)
- Hyperplasia rate
研究者
研究点 (58)
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