NCT00185484已完成3 期
Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers
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
- 1,113
- 主要终点
- Rate of unintended pregnancies (Pearl index)
研究概览
简要总结
The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy woman requesting contraception
- •Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
排除标准
- •Any conditions might interfere study outcome
研究组 & 干预措施
Arm 1
Experimental
干预措施: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) (Drug)
结局指标
主要结局
Rate of unintended pregnancies (Pearl index)
时间窗: 13 cycles of 28 days
次要结局
- Physical and gynecological examination(screening, cycle 6 and final examination)
- Vital signs(each visit)
- Body weight(each visit)
- Cervical smear(each visit)
研究者
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