作者: Hugh S. Taylor , Linda C. Giudice , Bruce A. Lessey , Mauricio S. Abrao , Jan Kotarski
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摘要: BackgroundEndometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. MethodsWe performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I II [EM-I EM-II]) evaluate the effects of doses elagolix — 150 mg once daily (lower-dose group) 200 twice (higher-dose as compared with placebo women surgically diagnosed endometriosis moderate or severe endometriosis-associated The primary efficacy end points were proportion who had clinical response respect nonmenstrual pain at months. Each these was measured clinically meaningful reduction score decreased stable use rescue analgesi...