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: 21 Feb 2018

At a glance

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

    • 21 Feb 2018 According to an AbbVie Media Release, data will be presented at an upcoming medical conference. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.
    • 21 Feb 2018 Results published in an AbbVie Media Release
    • 21 Feb 2018 Primary endpoint has been met. (Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Final Month), as reported in an AbbVie media release.
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