NCT00206583已完成3 期
A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
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
- 499
- 试验地点
- 29
- 主要终点
- Number of unintended pregnancies after 1 year
研究概览
简要总结
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. 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 women between the ages of 18 and 35 years requiring contraception
排除标准
- •Pregnancy, lactation, and contraindication of combined oral contraceptive
研究组 & 干预措施
EV/DNG (Qlaira, BAY86-5027)
Experimental
Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)
干预措施: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) (Drug)
结局指标
主要结局
Number of unintended pregnancies after 1 year
时间窗: Throughout 1 year of treatment
次要结局
- Bleeding pattern and cycle control parameters after 1 year(Throughout 1 year of treatment)
研究者
研究点 (29)
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