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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

NCT03194646 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1272

Last updated 2025-07-28

Study results available
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Summary

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

Conditions

  • Uterine Fibroids

Interventions

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen).

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen).

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen).

OTHER

Standard of care

Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)

DRUG

Vilaprisan (BAY1002670)

2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-05-10
Completion
2024-07-11
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • Finland
  • Hong Kong
  • Japan
  • Mexico
  • Norway
  • Poland
  • Russia
  • South Africa
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194646 on ClinicalTrials.gov