Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis

ObjectiveTo evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale worst pain associated with dysmenorrhea (NRS-DYS) nonmenstrual pelvic (NRS-NMPP) in women moderate to severe endometriosis-associated pain.DesignAnalysis data from two phase III randomized clinical trials (EM-I [NCT01620528] EM-II [NCT01931670]).SettingNot applicable.Patient(s)Premenopausal ages 18–49 years pain.Intervention(s)Participants both were 3:2:2 receive placebo, elagolix 150 mg once daily, or 200 twice daily 6 months.Main Outcome Measure(s)NRS-DYS NRS-NMPP.Result(s)EM-I enrolled 871 815 women. For patients global impression improvement at month 3, least-squares mean between baseline 3 was −3.6 EM-II) NRS-DYS −1.9 (EM-I) −2.0 (EM-II) NRS-NMPP. Standard errors measurement 2.99 2.86 1.74 1.71 Baseline half standard deviations 0.78 0.85 0.92 0.96 Based on these results, changes defined as reduction 4 points 2 NRS-NMPP.Conclusion(s)This study demonstrated utility responsiveness separate scales assess NMPP identified initial change. To pain. Analysis [NCT01931670]). Not applicable. Premenopausal Participants months. EM-I This