Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas Article

Full Text via DOI: 10.1097/AOG.0000000000003869 PMID: 32459423 Web of Science: 000570187600014

Cited authors

  • Simon, James A.; Al-Hendy, Ayman; Archer, David F.; Barnhart, Kurt T.; Bradley, Linda D.; Carr, Bruce R.; Dayspring, Thomas; Feinberg, Eve C.; Gillispie, Veronica; Hurtado, Sandra; Kim, JinHee; Liu, Ran; Owens, Charlotte D.; Muneyyirci-Delale, Ozgul; Wang, Alice; Watts, Nelson B.; Schlaff, William D.

Abstract

  • OBJECTIVE: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.; METHODS: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies.; RESULTS: From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean +/- SD age of this group was 42.4 +/- 5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}.; CONCLUSION: Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy.

Authors

Publication date

  • 2020

Published in

International Standard Serial Number (ISSN)

  • 0029-7844

Start page

  • 1313

End page

  • 1326

Volume

  • 135

Issue

  • 6