NCT01638910已完成3 期
A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest 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
- 955
- 主要终点
- Number of unintended pregnancies
研究概览
简要总结
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
- •Smokers may not exceed 35 years of age
排除标准
- •Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
- •Body mass index (BMI) > 32 kg/m2
- •Any disease or condition that may worsen under hormonal treatment
- •Undiagnosed abnormal genital bleeding
- •Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
- •Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
研究组 & 干预措施
EV/DNG (Qlaira, BAY86-5027)
Experimental
干预措施: EV/DNG (Qlaira, BAY86-5027) (Drug)
结局指标
主要结局
Number of unintended pregnancies
时间窗: Up to Cycle 13 (1 Cycle = 28 days)
次要结局
- Number of expected bleeding days(Up to Cycle 13 (1 Cycle = 28 days))
- Number of unexpected bleeding episodes(Up to Cycle 13 (1 Cycle = 28 days))
- Number of expected bleeding episodes(Up to Cycle 13 (1 Cycle = 28 days))
- Number of unexpected bleeding days(Up to Cycle 13 (1 Cycle = 28 days))
- Number of participants with Adverse Events as a Measure of Safety and Tolerability(Up to Cycle 13 (1 Cycle = 28 days))
研究者
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