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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Leiomyoma

Intervention / Treatment
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* Drug: BAY1002670
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: BAY1002670 [0.1mg]<br>0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: BAY1002670<br> <br> |
| Experimental: BAY1002670 [0.5mg]<br>0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: BAY1002670<br> <br> |
| Experimental: BAY1002670 [1.0mg]<br>1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: BAY1002670<br> <br> |
| Experimental: BAY1002670 [2.0mg]<br>2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: BAY1002670<br> <br> |
| Experimental: BAY1002670 [5.0mg]<br>5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: BAY1002670<br> <br> |
| Placebo Comparator: Placebo<br>Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment) |  | After three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of menstrual bleeding after treatment |  | Up to two months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK/PD, BAY1002670