NCT00185328已完成4 期
A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles
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
- 55
- 主要终点
- The relative change in the frequency of hot flushes
研究概览
简要总结
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
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
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with hot flushes
排除标准
- •Women with a contraindication for Hormone Replacement Therapy (HRT)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Estradiol/DRSP (Angeliq, BAY86-4891) (Drug)
结局指标
主要结局
The relative change in the frequency of hot flushes
时间窗: At baseline, week 4, 8, 12
次要结局
- The change in intensity of hot flushes(At baseline, week 4, 8)
- The relative change in frequency of hot flushes(At baseline, week 4, 8)
- The proportions of subjects with urogenital symptoms(At baseline, week 4, 8, 12)
- Bleeding pattern(At baseline, week 4, 8, 12)
- Adverse events collection(Collection of AE throughout the study period)
研究者
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