Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Clinical Trial ,Phase I

Intervention / Treatment
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* Drug: Vilaprisan (BAY 1002670)
* Drug: Vilaprisan Placebo
* Drug: Microgynon
* Drug: Microgynon Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COC + Vilaprisan<br>COC + Vilaprisan (BAY 1002670) | Drug: Vilaprisan (BAY 1002670)<br>* Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.<br>Drug: Microgynon<br>* Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)<br>Drug: Microgynon Placebo<br>* For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).<br>|
| Placebo Comparator: COC + Placebo<br>COC + Placebo | Drug: Vilaprisan Placebo<br>* Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.<br>Drug: Microgynon<br>* Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)<br>Drug: Microgynon Placebo<br>* For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5) |  | treatment day 57 to day 84 | 
| Number of subjects with a Hoogland score = 4 |  | treatment day 57 to day 84 |