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.
- 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
- 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
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