Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

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

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)