A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

Trial Profile

A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until Return of Menses, in Subjects With Myomas and Heavy Uterine Bleeding

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2016

At a glance

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

    • 21 Nov 2016 According to an Allergan media release, based on the data from this and other study the Health Canada approved Fibristal (ulipristal acetate, 5 mg) for the intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age.
    • 02 Jun 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 12 Mar 2013 New trial record
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