Obstet Gynecol 2022 Jun 2;139(6):1070-1081. Epub 2022 May 2.
Mayo Clinic, Rochester, Minnesota; the Carolina Woman's Research and Wellness Center, Durham, North Carolina; the Department of Clinical and Experimental Medicine, Unit of Obstetrics and Gynecology, Magna Graecia University of Catanzaro, Catanzaro, Italy; Myovant Sciences, Inc., Brisbane, California; Myovant Sciences GmbH, Basel, Switzerland; and the Department of Obstetrics and Gynecology, University of Chicago, Chicago, Illinois.
Objective: To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.
Methods: Two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2) were conducted in premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle). Read More