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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Ulipristal (Primary)
  • Indications Uterine leiomyoma
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms PEARL-I
  • Sponsors PregLem
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top