A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in 60 Healthy Tubal-ligated Women Aged 18 to 45 Years Investigating the Pharmacodynamic Effects of 5 Different Doses (0.1 - 5 mg) BAY1002670 After Daily Oral Administration Over 84 Days
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 73
- 主要终点
- Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
研究概览
简要总结
Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects
- •Sterilized by tubal ligation
- •Age 18-45 years
- •Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
- •At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
- •Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
排除标准
- •Regular use of medicines (incl. anabolics)
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- •Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- •Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
- •Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
研究组 & 干预措施
BAY1002670 [0.1mg]
0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: BAY1002670 (Drug)
BAY1002670 [0.5mg]
0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: BAY1002670 (Drug)
BAY1002670 [1.0mg]
1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: BAY1002670 (Drug)
BAY1002670 [2.0mg]
2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: BAY1002670 (Drug)
BAY1002670 [5.0mg]
5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: BAY1002670 (Drug)
Placebo
Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
时间窗: After three months
次要结局
- Return of menstrual bleeding after treatment(Up to two months after last treatment)