A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas.
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Ulipristal (Primary)
- Indications Uterine leiomyoma
- Focus Pharmacodynamics; Registrational; Therapeutic Use
- Acronyms PEARL-I
- Sponsors PregLem
- 27 Feb 2012 Results from this trial were used to support marketing approval of ulipristal for uterine leiomyoma in the EU.
- 02 Feb 2012 Results published in the New England Journal of Medicine.
- 01 Feb 2012 Results published in the New England Journal of Medicine, according to a PregLem media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History