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
Phase of Trial: Phase III
Latest Information Update: 10 Jul 2018
At a glance
- Drugs Relugolix (Primary) ; Estradiol/norethisterone
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- Acronyms LIBERTY 1
- Sponsors Myovant Sciences
- 10 Jul 2018 According to a Myovant Sciences media release, if the results are positive from the LIBERTY 1 and LIBERTY 2 studies, the company intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2019.
- 10 Jul 2018 According to a Roivant Sciences media release, the company has closed screening in this trial and data is expected in Q2 2019.
- 02 Feb 2017 New trial record