A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Phase 3

Terminated

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

• Registration Number: NCT03240523
• Lead Sponsor: Bayer

Brief Summary

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-21
• Study Start: 2017-07-31
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Primary Completion: 2020-06-28
• Study Completion: 2021-10-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 766

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 more than 30 mm and less than 120 mm
• Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A2: Vilaprisan (6/2 regimen)	Vilaprisan (BAY1002670)	Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Group A1: Vilaprisan (3/1 regimen)	Vilaprisan (BAY1002670)	Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Group A3/B (3/2 regimen)	Vilaprisan (BAY1002670)	Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.

Primary Outcome Measures

Name	Time	Method
Amenorrhea (yes/no)	At 3 months (at the end of treatment perid 1)	Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days.; For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.

Secondary Outcome Measures

Name	Time	Method
Amenorrhea (yes/no)	At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months	Defined as menstrual blood loss (MBL) \< 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
Percent change in volume of largest fibroid compared to baseline	At baseline, at 12 months and at 24 months	Measured by MRI (magnetic resonance imaging).
Total volume of menstrual blood loss	After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2	Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.
Number of bleeding days	After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2	From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days.
Absence of bleeding (spotting allowed)	Up to 24 months	Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).
Time to onset of controlled bleeding	Quarterly up to 24 months	Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.
HMB (Heavy Menstrual Bleeding) responder rate	By treatment period up to 24 months	Percentage of subjects with blood loss \< 80.00 mL per 28 days and 50% reduction compared to baseline \[assessed by MP\]
Endometrial histology	Up to 24 months	E.g., benign endometrium, presence or absence of hyperplasia or malignancy
Endometrial thickness	Up to 24 months

Trial Locations

Locations (139)

Paratus Clinical Pty Ltd; 🇦🇺 Blacktown, New South Wales, Australia

Paratus Clinical Wyong Complex; 🇦🇺 Kanwal, New South Wales, Australia

Women's Health and Research Institute of Australia-WHRIA; 🇦🇺 Sydney, New South Wales, Australia

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Queensland, Australia

Medizinische Universität Graz; 🇦🇹 Graz, Steiermark, Austria

Landeskrankenhaus Bregenz; 🇦🇹 Bregenz, Vorarlberg, Austria

Universitätsklinikum AKH Wien; 🇦🇹 Wien, Austria

AZ Jan Palfijn Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

CHU Saint-Pierre/UMC Sint-Pieter; 🇧🇪 Bruxelles - Brussel, Belgium

CU Saint-Luc/UZ St-Luc; 🇧🇪 Bruxelles - Brussel, Belgium

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