Effect of Elagolix in Women with Moderate to Severe Pelvic Tenderness or Induration: Results from Elaris EM-l and EM-II Clinical Trials

Study Objective Evaluate efficacy and safety of elagolix in women with endometriosis and moderate/severe pelvic tenderness or induration. Design Subset analyses of pooled 6-month, randomized, double-blind, placebo-controlled phase 3 studies, Elaris EM-I and EM-II. Setting Multicenter clinical trials. Patients or Participants Premenopausal women (18-49) with surgically diagnosed endometriosis and moderate/severe endometriosis-associated pain. Interventions Randomized 3:2:2 to placebo, elagolix 150mgQD, and elagolix 200mgBID. Measurements and Main Results Of 1686 women randomized/treated, 66% had moderate/severe pelvic tenderness and 35% had moderate/severe induration on pelvic exam at baseline. Among women with moderate/severe pelvic tenderness, the proportion of responders with a decrease in dysmenorrhea [placebo, 20.3%; 150mgQD elagolix, 43.3%; 200mgBID elagolix, 73.6%] and nonmenstrual pelvic pain (NMPP) [placebo, 34.6%; 150mgQD elagolix, 47.8%; 200mgBID elagolix, 56.6%] at M3 was statistically significant (P Conclusion In women with baseline moderate/severe pelvic tenderness or moderate/severe induration on exam, elagolix 150mgQD and 200mgBID significantly reduced dysmenorrhea and NMPP, and elagolix 200mgBID significantly reduced dyspareunia versus placebo. These results are consistent with the overall Elaris EM-I and EM-II results.