Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

Summary

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis. With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.

Timeline

Start

2018-07-04

Primary completion

2019-03-18

Completion

2020-11-26

Publications

• Taylor HS, Dong L, Haikonen J, Oppelt P, Tamussino K, Wenzl R, Faustmann T, Groettrup-Wolfers E, Ren X, Seitz C. Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial. F S Rep. 2024 Mar 11;5(2):189-196. doi: 10.1016/j.xfre.2024.03.002. eCollection 2024 Jun.

Drugs

Indications