NCT00185367已完成3 期
A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
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
- 798
- 试验地点
- 32
- 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, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers aged between 18 and 50 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
Experimental
干预措施: EV/DNG (Qlaira, BAY86-5027, SH T00658K) (Drug)
Arm 2
Active Comparator
干预措施: SH D 593 B (Miranova) (Drug)
结局指标
主要结局
Bleeding pattern
时间窗: 7 treatment cycles each consisting of 28 days
Number of unintended pregnancies
时间窗: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
次要结局
- Adverse event collection(7 treatment cycles each consisting of 28 days and follow-up period of 14 days)
研究者
研究点 (32)
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