Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Study Overview
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Brief Summary
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The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Official Title
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A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Vilaprisan (BAY1002670)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women, 18 years or older at the time of Visit 1 Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more) Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the menstrual pictogram (MP) Use of an acceptable non-hormonal method of contraception An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology 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 drugs Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) 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 including Abuse of alcohol, drugs, or medicines (eg: laxatives) Undiagnosed abnormal genital bleeding Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vilaprisan<br>2 treatment periods of 12 weeks without a break | Drug: Vilaprisan (BAY1002670)<br>* 2 mg, once daily, oral<br>|
| Placebo Comparator: Placebo<br>2 treatment periods of 12 weeks without a break | Drug: Placebo<br>* Once daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amenorrhea (yes/no) | Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram) | Up to 24 weeks (The last 28 days of treatment period 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heavy menstrual bleeding (HMB) response (yes/no) | Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline | Up to 24 weeks (the last 28 days of treatment period 2) | 
| Time to onset of amenorrhea | Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL. | Up to 24 weeks | 
| Time to onset of controlled bleeding | Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL. | Up to 24 weeks | 
| Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD) |  | Up to 24 weeks (the last 28 days of treatment period 2) | 
| Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy) |  | Up to 36 weeks | 
| Endometrial thickness |  | Up to 36 weeks |