Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

This study evaluated the efficacy and safety of elagolix, an oral gonadotropin releasing hormone (GnRH) antagonist, with and without add-back therapy (estradiol and norethindrone acetate) for managing heavy menstrual bleeding in women with uterine fibroids. Two identical, double-blind, randomized, placebo controlled phase 3 trials (Elaris UF-1 and UF-2) were conducted. Results showed that 68.5% (UF-1) and 76.5% (UF-2) of women receiving elagolix plus add back therapy met the primary endpoint (menstrual blood loss <80 mL and ≥50% reduction from baseline), compared to 8.7% and 10% in the placebo groups (P<0.001). Elagolix alone also demonstrated efficacy (84.1% and 77% response rates). Add back therapy mitigated hypoestrogenic effects, such as bone mineral density loss, while common adverse events included hot flushes and night sweats. The findings support elagolix with add back therapy as an effective treatment for fibroid associated bleeding.

This study evaluated the efficacy and safety of elagolix, an oral gonadotropin releasing hormone (GnRH) antagonist, with and without add-back therapy (estradiol and norethindrone acetate) for managing heavy menstrual bleeding in women with uterine fibroids. Two identical, double-blind, randomized, placebo controlled phase 3 trials (Elaris UF-1 and UF-2) were conducted. Results showed that 68.5% (UF-1) and 76.5% (UF-2) of women receiving elagolix plus add back therapy met the primary endpoint (menstrual blood loss <80 mL and ≥50% reduction from baseline), compared to 8.7% and 10% in the placebo groups (P<0.001). Elagolix alone also demonstrated efficacy (84.1% and 77% response rates). Add back therapy mitigated hypoestrogenic effects, such as bone mineral density loss, while common adverse events included hot flushes and night sweats. The findings support elagolix with add back therapy as an effective treatment for fibroid associated bleeding.