NCT00302666已完成3 期
Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy 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
- 1,315
- 主要终点
- Bleeding pattern
研究概览
简要总结
The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers aged between 18 and 40 years requiring contraception.
排除标准
- •Pregnancy or lactation.
- •Any conditions that might interfere with the outcome as well as all contraindications for OC use.
研究组 & 干预措施
Arm 1
Sham Comparator
干预措施: Valette (Dienogest/EE30, BAY86-5038) (Drug)
Arm 2
Sham Comparator
干预措施: Valette (Dienogest/EE30, BAY86-5038) (Drug)
结局指标
主要结局
Bleeding pattern
次要结局
- Safety, contraceptive efficacy
研究者
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