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: 24 Jul 2018

At a glance

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

    • 24 Jul 2018 According to AbbVie media release, AbbVie Receives U.S. FDA Approval of ORILISSA for the Management of Moderate to Severe Pain Associated with Endometriosis.
    • 23 May 2018 Results from ELARIS EM-I and EM-II studies, presented at the 23rd Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 30 Apr 2018 Results of pooled data from two phase 3 trials (Elaris EM-I and Elaris EM-II ) assessing baseline pain burden among women with moderate to severe endometriosis pain, were presented at the 66th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists.
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