Trial Profile

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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 09 Jul 2024

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At a glance

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.

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