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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Clinical Trial, Phase I

Intervention / Treatment
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* Drug: Vilaprisan (BAY1002670)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilaprisan [0.5mg]<br>0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days | Drug: Vilaprisan (BAY1002670)<br> <br> |
| Experimental: Vilaprisan [1mg]<br>1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days | Drug: Vilaprisan (BAY1002670)<br> <br> |
| Experimental: Vilaprisan [2mg]<br>2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days | Drug: Vilaprisan (BAY1002670)<br> <br> |
| Experimental: Vilaprisan [4mg]<br>4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days | Drug: Vilaprisan (BAY1002670)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoogland score during treatment, day 9 to day 28 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | Day 9 to 28 | 
| Hoogland score during treatment, day 63 to day 84 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | Day 63 to 84 | 
| Hoogland score during follow up cycle 1 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | 4 weeks following treatment period | 
| Hoogland score during follow up cycle 2 | based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations | 4 weeks following follow up cycle 1 | 
| Number of subjects without bleeding/spotting |  | After three month treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling |  | After three month treatment | 
| Number of subjects with TEAEs (treatment-emergent adverse events) |  | After three month treatment and during follow-up (up to 60 days) | 
| Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes) |  | After three month treatment and during follow-up (up to 60 days) |