NCT00185237已完成3 期
A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.
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
- 165
- 主要终点
- Relative change in frequency of hot flushes
研究概览
简要总结
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma 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
- •Evidence of postmenopausal status
排除标准
- •Contraindication to estrogen therapy
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Menostar (estradiol transdermal delivery system) (Drug)
结局指标
主要结局
Relative change in frequency of hot flushes
时间窗: 12 weeks
次要结局
- Changes in vaginal pH(12 weeks)
- Changes in vaginal maturation index(12 weeks)
- Safety(12 weeks)
- Bleeding profile(12 weeks)
- Change in intensity of hot flushes(12 weeks)
- Occurrence of urogenital symptoms(12 weeks)
- Change in MENQOL (menopausal quality of life questionaire)(12 weeks)
研究者
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