An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Latest Information Update: 07 Sep 2023
At a glance
- Drugs Estradiol/norethisterone acetate/relugolix (Primary)
- Indications Uterine leiomyoma
- Focus Therapeutic Use
- Acronyms Liberty RWS
- Sponsors Myovant Sciences
- 02 Sep 2023 Results assessing the 2-year relugolix CT efficacy and safety results of the phase 3 LIBERTY randomized withdrawal study (RWS) published in the American Journal of Obstetrics and Gynecology
- 02 Jun 2022 According to a Myovant Sciences media release, based on results from this study the U.S. FDA accepted for review a supplemental New Drug Application for MYFEMBREE. The sNDA proposes updates to MYFEMBREE's United States Prescribing Information based on this trial results. The FDA set a target action date of January 29, 2023 for this sNDA under the Prescription Drug User Fee Act (PDUFA).
- 22 Apr 2022 Status changed from active, no longer recruiting to completed.