M12-665 (n=872) is a Phase 3, randomized, double-blind, placebo-controlled, 24-week study aimed to evaluate the safety and efficacy of elagolix in women ages 18–49 with moderate-to-severe endometriosis-associated pain.
After six months of treatment , both elagolix 150mg once daily and elagolix 200mg twice daily met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain (NMPP) and menstrual pain (dysmenorrhea), associated with endometriosis at Month 3 and 6 as measured by the Daily Assessment of Endometriosis Pain scale (P<0.001).
Elagolix works by inhibiting gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland, reducing circulating sex hormone levels. M12-671, a second Phase 3, randomized, multinational, double-blind, placebo-controlled trial is ongoing and results are anticipated in late 2015.
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