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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2021

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At a glance

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

Most Recent Events

  • 06 Aug 2020 Results (n=1686) of pooled analysis of two studies (ELARIS I and II) assessing health-related quality of life measured by EP-30, published in the Obstetrics and Gynecology.
  • 20 May 2020 Results of post hoc pooled analysis of ELARIS I and II trial quantifying changes in health-related quality of life (HRQOL) among patients with endometriosis who experience a clinically meaningful reduction in dyspareunia presented at the 25th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
  • 12 Nov 2019 Results of post hoc analysis utilized data from two phase III, randomized, double-blind, placebo-controlled clinical studies (EM-I and EM-II) which evaluated the efficacy of elagolix among women with moderate-to-severe endometriosis-related painpublished in the American Journal of Obstetrics and Gynecology

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