NCT00356447已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 249
- 主要终点
- Frequency of hot flushes
研究概览
简要总结
The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany 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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese postmenopausal women with moderate to severe vasomotor symptoms
排除标准
- •History of steroid hormone dependent malignant disease
- •Known or suspected malignant or premalignant disease
- •Current or history of severe heart, liver, renal, psychiatric disease
- •Hyperlipemia
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Estradiol/DRSP (Angeliq, BAY86-4891) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of hot flushes
时间窗: From baseline to week 16
Change in intensity of hot flushes
时间窗: From baseline to week 16
次要结局
- Global clinical impression(From baseline to week 16)
- Vaginal Bleeding pattern(From baseline to week 16)
- Change in other climacteric symptoms(From baseline to week 16)
研究者
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