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From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) - all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.).
Published: January 2020
AI Article Synopsis
Article 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<0.001 for both trials). Among the women who received elagolix alone, the primary end point was met in 84.1% of 104 women in UF-1 and in 77% of 95 women in UF-2. Hot flushes (in both trials) and metrorrhagia (in UF-1) occurred significantly more commonly with elagolix plus add-back therapy than with placebo. Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy.
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.).
