This study assessed the impact of elagolix, an oral gonadotropin-releasing hormone antagonist, on workplace productivity in uterine fibroids (UF) patients with heavy menstrual bleeding (HMB).METHODS:
M12-813 was a Phase IIb, randomized, double-blind, placebo-controlled trial with 6-month treatment period in premenopausal UF patients with HMB (>80 mL menstrual blood loss per month). M12-813 had two cohorts: elagolix 300mg twice daily (cohort 1) and elagolix 600mg once daily (cohort 2). Each cohort had four arms: placebo, elagolix alone, and two elagolix plus add-back arms (low dose [LDA]: estradiol [E2] 0.5mg/norethindrone acetate [NETA] 0.1mg and standard dose [SDA]: 1.0mg E2/0.5mg NETA). UF-related workplace productivity hours lost to absenteeism and presenteeism (reduced productivity while at work) were measured at baseline and month 6 using the health-related productivity questionnaire. Changes from baseline were compared between elagolix arms and placebo utilizing analysis of covariance.RESULTS:
Cohort 1 included 204 women. At month 6, larger reductions in least-squared (LS) mean hours lost due to absenteeism were observed for elagolix 300mg BID, elagolix 300mg BID+LDA and elagolix 300mg BID+SDA (LS Means: -2.2, -2.6, and - 2.6 hours, respectively) compared to placebo (LS Means:-1.0 hours). P-values were <0.05 for both elagolix plus add-back arms. Reductions in LS mean hours lost due to presenteeism were greater for elagolix 300mg BID, elagolix 300mg BID+LDA and elagolix 300mg BID+SDA (LS Means: -6.8, -7.6, and -9.1 hours, respectively) than placebo (LS means: -2.9 hours); P-value was <0.01 in elagolix 300mg BID + SDA arm.CONCLUSION:
Elagolix+ SDA reduces UF-related absenteeism and presenteeism.