Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age

This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.

Inclusion Criteria:

• Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
• Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
• Pre-treatment cycle assessed as ovulatory and not longer than 44 days

Exclusion Criteria:

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
• Known or suspected liver disorders
• Amenorrhea for more than 3 months within the last 6 months before the first screening examination
• Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
• Positive urine pregnancy test
• Regular use of medicines