Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Summary

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan 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

2018-01-17

Primary completion

2019-06-09

Completion

2022-04-06

Outcome

Met primary endpoint

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

paper amenorrhea was observed more frequently in women treated with vilaprisan than in those who received placebo (83.3% vs. 0%, P<.0001) PMID 37437885 ↗

Publications

• Al-Hendy A, Zhou YF, Faustmann T, Groettrup-Wolfers E, Laapas K, Parke S, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial. F S Sci. 2023 Nov;4(4):317-326. doi: 10.1016/j.xfss.2023.06.003. Epub 2023 Jul 10.

Drugs

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

Indications