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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2022

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At a glance

  • Drugs Ulipristal (Primary) ; Leuprorelin
  • Indications Uterine leiomyoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PEARL-II
  • Sponsors PregLem

    • Most Recent Events

    • 15 Jan 2021 According to a Gedeon Richter media release, the European Commission (EC) implemented a decision concerning the marketing authorisations of ulipristal acetate 5 mg (Esmya) as a result of cases of serious liver injury. This decision follows the opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 13 November 2020 and is applicable for all Member States in the European Economic Area.
    • 04 Sep 2020 According to a European Medicines Agency media release, the PRAC recommendation will now be forwarded to EMA's human medicines committee (CHMP), which will adopt the Agency's opinion. EMA's human medicines committee (CHMP), which will adopt the Agency's opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
    • 04 Sep 2020 According to a European Medicines Agency media release, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU. The use of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review.
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