A Phase III, multicentre, randomized, double-blind clinical study, investigating the efficacy and safety of repeated 12-week courses of daily 5mg or 10mg doses of PGL4001 for the long-term management of symptomatic uterine fibroids

Trial Profile

A Phase III, multicentre, randomized, double-blind clinical study, investigating the efficacy and safety of repeated 12-week courses of daily 5mg or 10mg doses of PGL4001 for the long-term management of symptomatic uterine fibroids

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2016

At a glance

  • Drugs Ulipristal (Primary)
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PEARLIV
  • 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.
    • 15 Oct 2015 Results published in the Fertility and Sterility
    • 09 Oct 2015 According to a Gedeon Richter media release, results from this trial were presented at the European Society of Gynaecological Endoscopy (ESGE) Congress.
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