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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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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