A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2017

At a glance

  • Drugs Elagolix (Primary)
  • Indications Endometriosis; Pain
  • Focus Registrational; Therapeutic Use
  • Acronyms EM-I; VIOLET-PETAL
  • Sponsors Abbott Laboratories; AbbVie
  • Most Recent Events

    • 27 Oct 2017 According to an Abbvie media release, the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, being investigated for the management of endometriosis with associated pain. AbbVie expects the Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review will be in Q2 2018.
    • 06 Sep 2017 According to an Abbvie media release, has submitted a New Drug Application (NDA) to the US FDA for elagolix for the management of endometriosis with associated pain.
    • 03 Aug 2017 According to a AbbVie media release, data from this trial was published in the New England Journal of Medicine
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