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

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

Outcome

Met primary endpoint

Stopped: “Due to a change in the development program, the study was closed prematurely.”

registry analysis (superiority test); Vilaprisan (A1) vs Placebo+Vilaprisan (B1) vs Vilaprisan+Placebo (B2); p <.0001 NCT03400956 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vilaprisan	Other / unclassified	2 mg	Oral

Indications