NCT00185419已完成3 期
An Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 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
- 842
- 主要终点
- The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese female requesting contraceptives
排除标准
- •Vascular, metabolic, hepatic, renal, oncologic and other diseases
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Yasmin (Drug)
Arm 2
Active Comparator
干预措施: Marvelon (Drug)
结局指标
主要结局
The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.
时间窗: 13 treatment cycles (1 cycle= 28 days)
次要结局
- Weight changes(13 treatment cycles)
- Contraceptive reliability(13 treatment cycles)
- Effects on skin condition(13 treatment cycles)
- Changes in MDQ subscale scores(13 treatment cycles)
- Adverse Events(the whole study period)
研究者
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