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- W1988960012 abstract "To evaluate efficacy and safety of elagolix, a novel oral GnRH antagonist, for the treatment of endometriosis-associated pelvic pain. A Phase 2, randomized, double-blind, placebo-controlled, parallel group study of women with surgically confirmed endometriosis, and moderate or severe dysmenorrhea and nonmenstrual pelvic pain (NMPP) at baseline, who received elagolix 150mg q.d. (n = 66) or placebo (n = 66) for 8 weeks followed by 16 week open-label treatment with elagolix 150mg q.d. Assessment of dysmenorrhea, NMPP, dyspareunia and endometriosis-related analgesic use was recorded daily. Changes from baseline in the monthly mean (1 month = 4 weeks) of daily pain scores (0-3 scale) and percent of days with analgesic use were summarized and analyzed by ANCOVA. For all assessments, the average reduction from baseline to week 8 was significantly greater with elagolix compared with placebo (dysmenorrhea -1.1 vs -0.4, NMPP -0.5 vs -0.2, dyspareunia -0.6 vs -0.2, percent days with analgesic use -21.6% vs. -9.2%, P<0.01 for all). Additional improvements were observed for elagolix patients during the open-label treatment period; patients who were initially randomized to placebo had comparable improvements by week 24 (dysmenorrhea -1.4 and -1.3, NMPP -0.8 and -0.5, dyspareunia -0.8 and -0.6, percent days with analgesic use -29.2% and -20.6%; elagolix and placebo, respectively). Quality of life (QoL, EHP-5) and patient's global impression of change (PGIC) were significantly improved with elagolix treatment consistent with reductions in pain. Over the 24 week study period, the most commonly occurring adverse events in patients receiving elagolix were nausea, headache, and hot flush, each of which occurred in 9.9% of patients. Elagolix treatment was well tolerated and resulted in consistent, sustained reduction in dysmenorrhea and NMPP and improvements in QoL and PGIC in women with moderate to severe endometriosis-associated pelvic pain." @default.
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- W1988960012 date "2011-09-01" @default.
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- W1988960012 title "A novel oral GnRH antagonist, elagolix, is effective for reducing endometriosis-associated pelvic pain: results of a 24-week randomized study" @default.
- W1988960012 doi "https://doi.org/10.1016/j.fertnstert.2011.07.171" @default.
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