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• W2975204414 abstract "Adenomyosis is a benign lesion within the myometrium associated with heavy menstrual bleeding (HMB) and dysmenorrhea, and commonly co-exists with uterine fibroids (UF). Adenomyosis is also present in 15-57% of hysterectomy specimens with leiomyoma (Genc M, et al, 2015; Taran FA, et al, 2010). This analysis evaluated the efficacy and safety of elagolix, an oral, gonadotropin-releasing hormone receptor antagonist, with add-back therapy in a subset of women with UF, HMB and co-existing adenomyosis. Data were pooled from two 6-month, randomized, double-blind, placebo-controlled phase 3 studies, Elaris UF-1 and UF-2. Premenopausal women (18-51 years) with ultrasound-confirmed diagnosis of UF and HMB (>80mL menstrual blood loss [MBL]/cycle) were randomized 1:1:2 to placebo, elagolix 300mg twice daily (BID), or elagolix 300mg BID with 1mg estradiol/0.5mg norethindrone acetate (E2/NETA) once daily. This subset analysis was conducted in women with HMB associated with UF and co-existing adenomyosis diagnosed by ultrasound and/or MRI at baseline (BL). The primary endpoint was the proportion of women with <80mL MBL during the final month and ≥50% reduction in MBL from BL to the final month. MBL and the diagnosis of HMB was assessed with the alkaline hematin method. Adverse events (AEs) were monitored. Of 790 women treated, 16% had ultrasound and/or MRI diagnosed adenomyosis at BL. Pooled data demonstrated that the proportion of responders for the primary endpoint was significantly greater (P<0.001) for elagolix+E2/NETA [76.8% (95% CI, 65.84, 87.82)] compared to placebo [12.1% (95% CI, 0.97, 23.150)]. AEs reported in the adenomyosis subset included hot flushes, night sweats, headache, and nausea. In women with HMB associated with UF and co-existing adenomyosis at BL, elagolix +E2/NETA significantly reduced MBL versus placebo similar to the all-subject group. AEs reported in this group were similar to the all subject group. These data suggest that further studies investigating the effect of elagolix in women with HMB associated with UF and adenomyosis may be warranted." @default.
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• W2975204414 date "2019-09-01" @default.
• W2975204414 modified "2023-10-17" @default.
• W2975204414 title "Phase 3 trial results: efficacy and safety of elagolix in a subset of women with uterine fibroids and adenomyosis" @default.
• W2975204414 doi "https://doi.org/10.1016/j.fertnstert.2019.07.1335" @default.
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