NCT00206622已完成4 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 425
- 主要终点
- Lowest effective dose in decreasing the frequency and severity of hot flushes
研究概览
简要总结
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopause
- •Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)
排除标准
- •Hormonal treatment
- •Contraindication to estrogen/progestogen therapy
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Climara PRO (Estradiol / Levonorgestrel transdermal) (Drug)
Arm 2
Active Comparator
干预措施: Menostar (Estradiol transdermal) (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo transdermal (Drug)
结局指标
主要结局
Lowest effective dose in decreasing the frequency and severity of hot flushes
次要结局
- Other symptoms related to menopause
研究者
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