NCT00220324已完成3 期
Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to 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
- 840
- 主要终点
- Unadjusted Pearl Index
研究概览
简要总结
The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women requiring contraception
排除标准
- •Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Minisiston (SH D00342A) (Drug)
结局指标
主要结局
Unadjusted Pearl Index
时间窗: After 13 cycles of intake
次要结局
- Bleeding pattern(After 13 cycles of intake)
- Cycle control(After 13 cycles of intake)
- Adjusted Pearl Index(After 13 cycles of intake)
- Cumulative pregnancy rate(After 13 cycles of intake)
研究者
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