LIBERTY 1: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy & Safety Study of Relugolix Co-Administered With/Without Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 26 Nov 2018
At a glance
- Drugs Relugolix (Primary) ; Estradiol/norethisterone
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- Acronyms LIBERTY 1
- Sponsors Myovant Sciences
- 17 Nov 2018 Planned End Date changed from 1 Jun 2019 to 30 Dec 2019.
- 17 Nov 2018 Planned primary completion date changed from 1 Dec 2018 to 30 Jun 2019.
- 08 Nov 2018 According to a Myovant Sciences media release, a New Drug Application (NDA) filing expected in the fourth quarter of 2019.