NCT02403401已完成3 期
Multi-center, Open-label, Single-arm Study to Assess the Safety and Contraceptive Efficacy of a Levonorgestrel-containing Intravaginal Ring During a Treatment Period of One Year in Healthy Women 18 to 35 Years of Age
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
- 1,471
- 主要终点
- Pregnancy rate (Pearl Index)
研究概览
简要总结
Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female subject requesting contraception and willing to use the IVR
- •Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- •History of regular cyclic menstrual periods
- •Subject is willing and able to attend the scheduled study visits and comply with study procedures
排除标准
- •Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
- •Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator
- •Undiagnosed abnormal genital bleeding
- •Wish for pregnancy during the study
- •Major surgery scheduled during the study period
研究组 & 干预措施
Levonorgestrel (BAY98-7196)
Experimental
Vaginal ring containing 170 mg levonorgestrel
干预措施: Levonorgestrel (BAY98-7196) (Drug)
结局指标
主要结局
Pregnancy rate (Pearl Index)
时间窗: Up to 12 months
Pearl Index = Number of pregnancies per 100 woman-years of exposure
次要结局
- Cumulative failure rate(Up to 12 months)
研究者
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