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

Phase 3

Withdrawn

• Conditions: Uterine Fibroids
• Interventions: Drug: Placebo; Drug: Vilaprisan (BAY1002670)

• Registration Number: NCT03699176
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2018-10-27
• Primary Completion: 2019-12-25
• Study Completion: 2019-12-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 treatment periods of 12 weeks without a break
Vilaprisan	Vilaprisan (BAY1002670)	2 treatment periods of 12 weeks without a break

Primary Outcome Measures

Name	Time	Method
Amenorrhea (yes/no)	Up to 24 weeks (The last 28 days of treatment period 2)	Defined as menstrual blood loss (MBL) \<2 mL (based on menstrual pictogram)

Secondary Outcome Measures

Name	Time	Method
Time to onset of amenorrhea	Up to 24 weeks	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.
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)
Heavy menstrual bleeding (HMB) response (yes/no)	Up to 24 weeks (the last 28 days of treatment period 2)	Defined as blood loss \<80.00 mL during the last 28 days of treatment and \>50% reduction compared to baseline
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)	Up to 36 weeks
Time to onset of controlled bleeding	Up to 24 weeks	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.
Endometrial thickness	Up to 36 weeks

Trial Locations

Locations (8)

Ena Odori Clinic; 🇯🇵 Sapporo, Hokkaido, Japan

Asahi clinic; 🇯🇵 Takamatsu, Kagawa, Japan

Matsudo City General Hospital; 🇯🇵 Matsudo, Chiba, Japan

Tokeidai Memorial Clinic; 🇯🇵 Sapporo, Hokkaido, Japan

Japanese Red Cross Kumamoto Hospital; 🇯🇵 Kumamoto, Japan

Funabashi Municipal Medical Center; 🇯🇵 Funabashi, Chiba, Japan

Kagawa Prefectural Central Hospital; 🇯🇵 Takamatsu, Kagawa, Japan

Unoki Clinic; 🇯🇵 Kagoshima, Japan