NCT02131662

Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

A Randomized, Parallel-group, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy and Safety of Different Doses of BAY1002670 in Subjects With Uterine Fibroids Over 3 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	BAY1002670	Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
DRUG	BAY1002670	Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
DRUG	BAY1002670	Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
DRUG	BAY1002670	Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
DRUG	Placebo	Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

Timeline

• Start date: 2014-05-15
• Primary completion: 2016-05-04
• Completion: 2016-05-04
• First posted: 2014-05-06
• Last updated: 2017-12-08
• Results posted: 2017-12-08

Locations

105 sites across 13 countries: United States, Belgium, Bulgaria, Canada, Czechia, Finland, Germany, Hungary, Japan, Norway, Spain, Sweden, Switzerland

Regulatory

• FDA-regulated drug study