A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.
Phase of Trial: Phase III
Latest Information Update: 06 Nov 2017
At a glance
- Drugs Ulipristal (Primary) ; Leuprorelin
- Indications Uterine leiomyoma
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PEARL-II
- Sponsors PregLem
- 28 Feb 2012 Results from this trial were used to support marketing approval of ulipristal for uterine leiomyoma in the EU.
- 07 Feb 2012 Primary endpoint 'Clinical-response (bleeding control rate)' has been met.
- 02 Feb 2012 Results published in the New England Journal of Medicine.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History