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
Price :
$35
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At a glance
- Drugs Elagolix (Primary) ; Estradiol/norethisterone
- Indications Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Acronyms ELARIS UF-II; Replicate Study
- Sponsors AbbVie
- 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.