Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial.

ABSTRACT:

Objective

To evaluate the efficacy and safety of 2 doses of vilaprisan vs. placebo in participants with symptomatic endometriosis.

Design

Multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial (NCT03573336). The initially planned sample size was 315 patients. Recruitment was paused to assess long-term toxicity findings in rodents; although the findings were assessed as likely to be of limited clinical relevance in humans, the study was closed by the sponsor. During the pause, enrolled patients completed 3 or 6 months of treatment per their assigned regimen.

Setting

University hospitals, a regional hospital, and a private clinic.

Patients

Premenopausal adults with confirmed endometriosis and moderate-to-severe pelvic pain (≥4/10

SUBMITTER: Taylor HS 

PROVIDER: S-EPMC11228778 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature