A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).

Official Title
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An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding

Conditions
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Uterine Fibroids and Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: Vilaprisan (BAY1002670)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Diagnosis of uterine fibroid(s) documented by ultrasound at screening Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s) Good general health Normal or clinically insignificant cervical smear An endometrial biopsy performed during the screening period, without significant histological disorder Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study Exclusion Criteria: Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) Hypersensitivity to any ingredient of the study drug Any condition requiring immediate blood transfusion Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Abuse of alcohol, drugs, or medicines (e.g., laxatives) Use of other treatments that might interfere with the conduct of the study or the interpretation of the results Undiagnosed abnormal genital bleeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group A1<br>4 treatment periods of 12 weeks, each separated by 1 bleeding episode | Drug: Vilaprisan (BAY1002670)<br>* 2mg, once daily, oral<br>|
| Experimental: Treatment Group A2<br>2 treatment periods of 24 weeks, separated by 2 bleeding episodes | Drug: Vilaprisan (BAY1002670)<br>* 2mg, once daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse event |  | Up to one year and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bleeding days |  | Up to one year and 3 months |