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: 18 Aug 2017
At a glance
- Drugs Elagolix (Primary) ; Ethinylestradiol/norethisterone
- Indications Menstruation disorders; Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Sponsors AbbVie
- 03 Aug 2017 According to Neurocrine Biosciences media release, based on the data from this and other (CTP-700260982) 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.