A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 Months in Healthy Women of Reproductive Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
研究概览
简要总结
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 female premenopausal subjects
- •Age: 18 to 35 years (inclusive)
- •Body mass index (BMI) : ≥18 and ≤30 kg/m²
- •Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
排除标准
- •Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
- •presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
研究组 & 干预措施
COC + Vilaprisan
COC + Vilaprisan (BAY 1002670)
干预措施: Vilaprisan (BAY 1002670) (Drug)
COC + Vilaprisan
COC + Vilaprisan (BAY 1002670)
干预措施: Microgynon (Drug)
COC + Vilaprisan
COC + Vilaprisan (BAY 1002670)
干预措施: Microgynon Placebo (Drug)
COC + Placebo
COC + Placebo
干预措施: Vilaprisan Placebo (Drug)
COC + Placebo
COC + Placebo
干预措施: Microgynon (Drug)
COC + Placebo
COC + Placebo
干预措施: Microgynon Placebo (Drug)
结局指标
主要结局
Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
时间窗: treatment day 57 to day 84
Number of subjects with a Hoogland score = 4
时间窗: treatment day 57 to day 84
次要结局
未报告次要终点