Document Type
Article
Publication Date
1-23-2020
Abstract
BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.
METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) 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. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation.
RESULTS: 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, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P
CONCLUSIONS: Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.).
Recommended Citation
Schlaff, William D.; Ackerman, Ronald T.; Al-Hendy, Ayman; Archer, David F.; Barnhart, Kurt T.; Bradley, Linda D.; Carr, Bruce R.; Feinberg, Eve C.; Hurtado, Sandra M.; Kim, JinHee; Liu, Ran; Mabey, R. Garn; Owens, Charlotte D.; Poindexter, Alfred; Puscheck, Elizabeth E.; Rodriguez-Ginorio, Henry; Simon, James A.; Soliman, Ahmed M.; Stewart, Elizabeth A.; Watts, Nelson B.; and Muneyyirci-Delale, Ozgul, "Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids." (2020). Department of Obstetrics and Gynecology Faculty Papers. Paper 59.
https://jdc.jefferson.edu/obgynfp/59
PubMed ID
31971678
Language
English
Comments
From the New England Journal of Medicine, Schlaff et al., "Elagolix for heavy menstrual bleeding in women with uterine fibroids", Volume No 382(4), Pages 328-340. Copyright © 2020 Massachusetts Medical Society. Reprinted with permission
https://doi.org/10.1056/NEJMoa1904351