A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.

Trial Profile

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2016

At a glance

  • Drugs Ulipristal (Primary) ; Norethisterone
  • Indications Uterine haemorrhage; Uterine leiomyoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PEARL-III
  • Sponsors PregLem
  • Most Recent Events

    • 09 Jun 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.(Parent trial; NCT01156857).
    • 02 Jun 2011 New source identified (European Clinical Trials Database).
    • 16 Dec 2010 Planned end date changed from 1 Mar 2012 to 1 Jan 2014 as reported by ClinicalTrials.gov.
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