A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Trial Profile

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2018

At a glance

  • Drugs Ulipristal (Primary)
  • Indications Uterine haemorrhage; Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms Venus I
  • Sponsors Actavis; Allergan
  • Most Recent Events

    • 28 Feb 2018 According to an Allergan media release, the Company has been notified by the U.S. Food and Drug Administration (FDA) that the review of the New Drug Application (NDA) for ulipristal acetate has been extended and the PDUFA target action date is set for August 2018 to provide time for a full review of the file.
    • 05 Feb 2018 Results published in the Obstetrics and Gynecology
    • 10 Oct 2017 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, for the treatment of abnormal uterine bleeding in women with uterine fibroids with Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018.
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