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: 03 Aug 2017

At a glance

  • Drugs Elagolix (Primary)
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie
  • Most Recent Events

    • 03 Aug 2017 According to Neurocrine Biosciences media release, based on the data from this and other (CTP-700267034) study will form the basis for an anticipated 2019 supplemental NDA submission to the FDA for the approval of elagolix in the treatment of uterine fibroids.
    • 13 Jun 2017 Planned End Date changed from 16 Dec 2018 to 15 Jan 2019.
    • 13 Jun 2017 Status changed from recruiting to active, no longer recruiting.
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