Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

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

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)

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Principal Investigators

• Bayer Study Director · Bayer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• Austria
• Belgium
• Bulgaria
• Czechia
• Finland
• Germany
• Hungary
• Italy
• Lithuania
• Netherlands
• Norway
• Poland
• Portugal
• Spain
• Sweden
• United Kingdom

Study Locations