NCT00335218已完成4 期
A Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled, Two-arm, Phase IV Study to Investigate the Influence of a Continuous Combined Estrogen-progestin Regimen Containing 2 mg Estradiol Valerate and 2 mg Dienogest (Climodien® / Lafamme®) on the Fat Distribution in Otherwise Healthy Early Postmenopausal Women
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
- 67
- 主要终点
- Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
研究概览
简要总结
The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy early postmenopausal women
- •BMI between 25 and 30
排除标准
- •Contra-indication(s) for hormone treatment
- •Metabolic diseases
- •Concomitant medication with influence on lipid metabolism
研究组 & 干预措施
Arm 1
Experimental
干预措施: Climodien / Lafamme (BAY86-5027) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Individual relative change of abdominal visceral fat measured by magnetic resonance imaging
时间窗: Baseline and after 24 weeks of treatment
次要结局
- Adverse events collection(During whole study period)
- Parameters of body composition and lipid metabolism(Baseline and after 24 weeks of treatment)
研究者
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