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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2022

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At a glance

  • Drugs Elagolix (Primary) ; Estradiol/norethisterone
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELARIS UF-I
  • Sponsors AbbVie

Most Recent Events

  • 01 May 2022 Results of pooled post hoc analysis assessed mean changes from baseline in menstrual blood loss ad adverse event from two study (ELARIS UF-1 and 2) published in the Journal of Women's Health
  • 20 Jul 2020 Results of pooled analysis of two studies (ELARIS UF-1 & 2) assessing safety and efficacy of elagolix (300mg BID) with add-back therapy (1 mg estradiol/0.5mg norethindrone acetate [E2/NETA]) in reducing heavy menstrual bleeding associated with uterine fibroids in various subgroups of women over 6-months of treatment, published in the American Journal of Obstetrics and Gynecology.
  • 29 May 2020 According to an AbbVie media release, Ayman Al-Hendy, is the investigator for the ELARIS UF-2 clinical trials.

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