NCT03194646

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,272 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-05-10
• Completion: 2024-07-11
• First posted: 2017-06-21
• Last updated: 2025-07-28
• Results posted: 2021-08-26

Locations

219 sites across 13 countries: United States, China, Czechia, Finland, Hong Kong, Japan, Mexico, Norway, Poland, Russia, South Africa, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study