A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent 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 Intermittent 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 II
  • 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.
    • 01 Nov 2017 Results of subgroup analysis presented at the American Society for Reproductive Medicine Scientific Congress 2017
    • 01 Nov 2017 Results presented at the American Society for Reproductive Medicine Scientific Congress 2017
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