A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Trial Profile

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 May 2018

At a glance

  • Drugs Elagolix (Primary)
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELARIS UF-II
  • Sponsors AbbVie
  • Most Recent Events

    • 26 Apr 2018 Planned End Date changed from 15 Jan 2019 to 16 Jan 2019.
    • 13 Mar 2018 Results published in the AbbVie Media Release
    • 13 Mar 2018 According to AbbVie media release, Primary endpoint has been met. (Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Final Month)
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