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

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

Research output: Contribution to journalArticle

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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02925494. FUNDING SOURCE: AbbVie Inc funded this study.

Original languageEnglish (US)
Pages (from-to)1313-1326
Number of pages14
JournalObstetrics and gynecology
Volume135
Issue number6
DOIs
StatePublished - Jun 1 2020

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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    Simon, J. A., Al-Hendy, A., Archer, D. F., Barnhart, K. T., Bradley, L. D., Carr, B. R., Dayspring, T., Feinberg, E. C., Gillispie, V., Hurtado, S., Kim, J. H., Liu, R., Owens, C. D., Muneyyirci-Delale, O., Wang, A., Watts, N. B., & Schlaff, W. D. (2020). Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstetrics and gynecology, 135(6), 1313-1326. https://doi.org/10.1097/AOG.0000000000003869