Elagolix for Heavy Menstrual Bleeding in Women with Uterine
Elagolix is an oral, nonpeptide GnRH antagonist that results in rapid, reversible suppression of gonadotropins and ovarian sex hormones in women. These effects occur within 24 hours after the initiation of treatment and can be readily reversed on discontinuation of the drug, owing to its short half-life. Elagolix is approved for the management of moderate-to-severe endometriosis-associated pain; when administered alone, it is associated with hypoestrogenic effects such as decreased bone mineral density and vasomotor symptoms that are consistent with its mechanism of action.

A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy.

Researchers conducted two 6-month phase 3 trials to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal “add-back” therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. Conclusively, the risk of heavy menstrual bleeding among premenopausal women with uterine fibroids was significantly lower
among women who received elagolix, at a dose of 300 mg twice daily with add-back therapy for 6 months than among those who received placebo.

Highlights:
- In two identical, placebo controlled, 6-month phase 3 trials involving women with heavy menstrual bleeding associated with uterine fibroids, menstrual blood loss was significantly lower among women who received elagolix with add-back therapy than among those who received placebo.
- Elagolix with add-back therapy was associated with a significantly greater mean reduction in menstrual blood loss from baseline to the final month,
- A higher percentage of women with suppression of bleeding, a greater mean reduction in menstrual blood loss from baseline to 6 months and 3 months, &
- A higher percentage of women with a low baseline hemoglobin level (less than 10.5 g per deciliter) who had an increase in the hemoglobin level that was greater than 2 g per deciliter at 6 months, and a greater mean reduction in menstrual blood loss from baseline to 1 month.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1904351?query=recirc_inIssue_bottom_article
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