ASSESSMENT OF COMMON ADVERSE EVENTS OF RELUGOLIX COMBINATION THERAPY IN PREMENOPAUSAL WOMEN TREATED FOR SYMPTOMATIC ESTROGEN-DRIVEN CONDITIONS: LIBERTY AND SPIRIT STUDIES

Abstract

Relugolix is a once-daily, oral nonpeptide gonadotropin-releasing hormone receptor antagonist being developed in combination with estradiol (E2) and norethindrone acetate (NETA) to treat heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) and moderate-to-severe pain associated with endometriosis (EM). In the Phase 3 LIBERTY 1/2 trials for UF (n=770), relugolix combination therapy (Rel-CT [once-daily relugolix 40 mg, E2 1 mg, NETA 0.5 mg]) reduced HMB vs placebo. In the SPIRIT 1/2 trials for EM (n=1251), Rel-CT reduced dysmenorrhea, non-menstrual pelvic pain and dyspareunia vs placebo.