NCT00185354已完成3 期
Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 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
- 422
- 主要终点
- Number of pregnancies
研究概览
简要总结
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteer aged 18-35, smokers 18-30
排除标准
- •Contraindications for using hormonal contraceptives
研究组 & 干预措施
Arm 2
Active Comparator
干预措施: SH P00331N (Drug)
Arm 1
Experimental
干预措施: BAY86-5016, SH P00331F (Drug)
结局指标
主要结局
Number of pregnancies
时间窗: 13 cycles
Bleeding pattern and cycle control
时间窗: 13 cycles
次要结局
- Adverse events collection(13 cycles)
- Physical and gynecological exam(13 cycles)
- Endometrial biopsy(13 cycles)
研究者
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