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: 09 Nov 2017

At a glance

  • Drugs Elagolix (Primary) ; Ethinylestradiol/norethisterone
  • Indications Menstruation disorders; Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie
  • Most Recent Events

    • 02 Nov 2017 Planned End Date changed from 7 Dec 2018 to 25 Jan 2018.
    • 02 Nov 2017 Planned primary completion date changed from 17 May 2018 to 25 Jan 2018.
    • 01 Nov 2017 According to an Neurocrine Biosciences media release, initial top-line data from the study are expected around the end of 2017.
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