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: 10 Oct 2017

At a glance

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

    • 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.
    • 09 May 2017 Results of subgroup analysis presented at the 65th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists
    • 19 Oct 2016 Results of Venus-I trial, presented at the 72nd Annual Meeting of the American Society for Reproductive Medicine.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top