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 (ASTEROID 2)

NCT02465814 Phase 2 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 2
Status	COMPLETED
Enrolment	120
Start date	2015-06
Completion	2016-10

Conditions

• Leiomyoma

Interventions

• Vilaprisan (BAY1002670)
• Vilaprisan (BAY1002670
• Vilaprisan (BAY1002670
• Vilaprisan (BAY1002670)
• Ulipristal
• Ulipristal
• Ulipristal

Primary outcomes

• Amenorrhea (yes/no) — From day 7 to day 84 of treatment.
  Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.

Countries

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