NCT00651599已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq(drospirenon2mg and Estradiol 1mg) in Postmenopausal Korean Women With Vasomotor Symptoms Over 3, 28 Day Treatment Cycle
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
- 90
- 主要终点
- Hot flush (frequency and severity)
研究概览
简要总结
Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Postmenopausal Korean women suffering from hot flushes
排除标准
- •Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) (Drug)
结局指标
主要结局
Hot flush (frequency and severity)
时间窗: Daily in pre-treatment and treatment period
次要结局
- Urogenital symptoms(Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment)
- Assessment of bleeding(daily in pre-treatment and treatment period)
- Menopausal symptoms(Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment)
研究者
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