Quality of Life in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids: Baseline Disease Burden from Elaris UF-1 and UF-2

Study Objective Report baseline Uterine Fibroid Symptoms Quality of Life Questionnaire (UFS-QoL) data from Elaris UF-1 and UF-2 to characterize disease burden from heavy menstrual bleeding (HMB) associated with uterine fibroids (UF). Design Elaris UF-1 (NCT02654054) and UF-2 (NCT02691494) were identical, phase 3, double-blind, randomized, placebo-controlled studies investigating safety and efficacy of elagolix alone or combined with hormonal add-back therapy for HMB associated with UF. Setting Outpatient in clinic/office. Patients or Participants Premenopausal women (n=790) aged 18–51 years with diagnosed UF and HMB (menstrual blood loss [MBL] >80 mL/cycle for ≥2 menses). Interventions N/A Measurements and Main Results A modified UFS-QoL (4-week recall) was conducted before study drug administration. UFS-QoL is a self-administered, 37-item, disease-specific questionnaire that measures symptom severity and health-related QoL (HRQoL; calculated from 6 subscales and scored 0–100). Lower HRQoL scores indicate worse QoL. At baseline, mean (standard deviation [SD]) age was 42.4 (5.4) years, and MBL was 239.7 (158.7) mL. Baseline total HRQoL score was low, reflecting low QoL (mean [SD], 42.9 [23.2]). Mean (SD) scores were generally low across HRQoL domains (concern, 28.1 [24.6]; activities, 40.9 [27.0]; energy/mood, 47.4 [25.3]; control, 54.2 [28.3]; self-consciousness, 39.9 [30.7]; sexual function, 47.5 [35.4]). In each HRQoL domain, the questions most frequently answered ‘most’ or ‘all’ of the time were how often symptoms made patients: feel concerned about soiling underclothes (80%; concern), decrease the amount of time on exercise or other physical activities (59%; activities), feel tired or worn out (68%; energy/mood), feel less productive (50%; control), feel conscious about the size and appearance of their stomach (57%; self-consciousness), and avoid sexual relations (46%; sexual function). Conclusion There was considerable baseline disease burden. Patients reported the greatest impacts to concern and self-consciousness. Common issues included concerns about soiling underclothes and feeling tired or worn out.