OBJECTIVES : Evaluate the impact of elagolix, an oral gonadotropin-releasing hormone antagonist, on health-related quality of life (HRQOL) measured by SF-12 in women with uterine fibroid (UF)-related heavy menstrual bleeding (HMB).

METHODS : Premenopausal women aged 18 to 51 years with HMB (> 80 mL blood loss per menstrual cycle) associated with UF were enrolled in a Phase 2b, randomized, placebo-controlled trial with 6-month treatment of elagolix. Trial consisted of two cohorts: elagolix 300 mg BID in cohort 1 and elagolix 600 mg QD in cohort 2. Each cohort had four arms: placebo, elagolix alone (E), elagolix plus low dose add-back [LDA] (estradiol [E2] 0.5 mg/norethindrone acetate 0.1 mg [NETA]), and elagolix plus standard dose add-back [SDA] (1.0 mg E2/0.5mg NETA). SF-12 questionnaire was administered at baseline and month 6. Least square changes in mean SF-12 scores at month 6 from baseline were compared between elagolix and placebo using ANCOVA models.

RESULTS : Cohort 1 included 253 women. Mean baseline physical component summary (PCS) scores were 45.5, 45.5, 44.9, and 43.6 for placebo, E alone, E+LDA and E+SDA, respectively (population norm = 50). Increases in mean (SE) PCS scores from baseline compared to placebo were 7.3 (1.4) in E alone (p<0.001), 4.9 (1.4) in E+LDA (p<0.001), and 2.8 (1.4) in E+SDA (p<0.05). Baseline mean mental component summary (MCS) scores were similar to PCS; changes in MCS in Elagolix groups were positive however not statistically significant from placebo. At month 6, mean scores in all domains of SF-12 improved in all Elagolix arms, with statistically significant improvements in bodily pain scores (p<0.001), from 38.3 to 53.7 for E alone, 41.1 to 51.2 for E+LDA, and 41.0 to 48.7 for E+SDA. Results for cohort 2 were similar.

CONCLUSIONS : Elagolix with and without add-back significantly improved HRQOL and reduced bodily pain in women with UF-related HMB.