drugset / Trial / NCT03400956

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

NCT03400956

Phase 3 Terminated 103 enrolled Bayer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids

Timeline

Start
2018-01-24
Primary completion
2019-03-23
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vilaprisan Other / unclassified 2 mg Oral

Indications