NCT02465814

Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Vilaprisan (BAY1002670)	Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
DRUG	Vilaprisan (BAY1002670	Placebo (12 weeks),Vilaprisan (12 weeks)
DRUG	Vilaprisan (BAY1002670	Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
DRUG	Vilaprisan (BAY1002670)	Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
DRUG	Ulipristal	Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
DRUG	Ulipristal	Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
DRUG	Ulipristal	Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-06-09
• Last updated: 2016-11-22

Locations

64 sites across 16 countries: Austria, Belgium, Bulgaria, Czechia, Finland, Germany, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom