LAUSR

Study Objective Evaluate influence of uterine fibroid (UF) size/location on the efficacy of elagolix with add-back therapy in women with heavy menstrual bleeding (HMB) associated with UF. Design Data was pooled from two 6-month, randomized, double-blind, placebo-controlled phase 3 studies, Elaris UF-1 and UF-2. Setting Outpatient in clinic/office Patients or Participants Premenopausal women (18-51 years) with HMB [>80mL menstrual blood loss (MBL)/cycle; alkaline hematin methodology] and ultrasound-confirmed UF diagnosis. Interventions Women were randomized 1:1:2 to placebo, elagolix 300mg twice daily (BID), or elagolix 300mg BID with 1 mg estradiol/0.5mg norethindrone acetate (E2/NETA) once daily. Measurements and Main Results This subgroup analysis evaluated the influence of UF location and size on the efficacy of elagolix+E2/NETA. Uterine volume, and size and location of UF were assessed by ultrasound. Subgroups were defined by baseline (BL) FIGO categories which were grouped FIGO 0-3, FIGO 4, or FIGO 5-8, median BL primary fibroid volume and median BL uterine volume. The primary endpoint was the proportion of women with Conclusion The effect of elagolix in reducing HMB associated with UF was not impacted by uterine volume, or UF location and size.