Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis

To determine if coexisting adenomyosis limits the efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy in reducing heavy menstrual bleeding in women with uterine fibroids. Pooled analysis of two identical, double-blind, randomized, placebo-controlle...

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Bibliographic Details
Published in:F&S Reports (Online) 2021-09, Vol.2 (3), p.338-346
Main Authors: Muneyyirci-Delale, Ozgul, Archer, David F., Owens, Charlotte D., Barnhart, Kurt T., Bradley, Linda D., Feinberg, Eve, Gillispie, Veronica, Hurtado, Sandra, Kim, Jin Hee, Wang, Alice, Wang, Hui, Stewart, Elizabeth A.
Format: Article
Language:English
Subjects:
Adenomyosis
elagolix
Original
uterine fibroids
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Summary:To determine if coexisting adenomyosis limits the efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy in reducing heavy menstrual bleeding in women with uterine fibroids. Pooled analysis of two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids [UF]-1 and UF-2). A total of 153 gynecological clinical care settings in the United States and Canada. Premenopausal women (18–51 years) with >80 mL of menstrual blood loss (MBL)/cycle and uterine fibroids with and without coexisting adenomyosis diagnosed by ultrasound and/or magnetic resonance imaging at baseline. Participants were randomized 1:1:2 to placebo, elagolix 300 mg twice daily alone, or elagolix 300 mg twice daily with estradiol 1 mg/norethindrone acetate 0.5 mg once daily. The primary endpoint was the proportion of women who had
ISSN:2666-3341
2666-3341
DOI:10.1016/j.xfre.2021.05.004