Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Phase 3

Terminated

• Conditions: Uterine Fibroids
• Interventions: Other: Standard of care; Drug: Vilaprisan (BAY1002670)

• Registration Number: NCT03194646
• Lead Sponsor: Bayer

Brief Summary

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Study Start: 2017-06-30
• Primary Completion: 2019-05-10
• Disposition First Submitted: 2020-03-17
• Results First Submitted: 2021-06-21
• Results First Submitted QC: 2021-08-04
• Disposition First Submitted QC: 2021-08-04
• Results First Posted: 2021-08-26
• Disposition First Posted: 2021-08-26
• Study Completion: 2024-07-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1272

Inclusion Criteria

• 18 years or older
• Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
• At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
• 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 (eg, laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
• Undiagnosed abnormal genital bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B(Standard of care)	Standard of care	Standard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment
A1(3/1 regimen)	Vilaprisan (BAY1002670)	2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
A2(6/2 regimen)	Vilaprisan (BAY1002670)	2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
A3(3/2 regimen)	Vilaprisan (BAY1002670)	2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break

Primary Outcome Measures

Name	Time	Method
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine	From baseline to about 1 year after start of treatment	The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.

Secondary Outcome Measures

Name	Time	Method
Number of Bleeding Days	Treatment phase: approximately 1 year	Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)	Up to 3 years (from study treatment start to end of study)	Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Change From Baseline in Endometrial Thickness	Treatment phase: approximately 1 year, follow-up phase: up to 2 years	Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck	Treatment phase: approximately 1 year, follow-up phase: up to 2 years	Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.

Trial Locations

Locations (219)

AMR - Mobile, AL; 🇺🇸 Mobile, Alabama, United States

Lynn Institute of the Ozarks; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences - Neurology; 🇺🇸 Little Rock, Arkansas, United States

M3 Wake Research San Diego - Alvarado; 🇺🇸 San Diego, California, United States

Doral Medical Research; 🇺🇸 Doral, Florida, United States

Suncoast Clinical Research - Palm Harbor; 🇺🇸 Palm Harbor, Florida, United States

Suncoast Clinical Research - New Port Richey; 🇺🇸 Trinity, Florida, United States

Center For Women's Care; 🇺🇸 Palos Heights, Illinois, United States

Southern Clinical Research Associates; 🇺🇸 Metairie, Louisiana, United States

M3 Wake Research - Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

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