• 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, JinHee Kim, Ran Liu, Charlotte D Owens, Ozgul Muneyyirci-Delale, Alice Wang, Nelson B Watts, and William D Schlaff.
• George Washington University, IntimMedicine Specialists, Washington, DC; University of Illinois at Chicago, Chicago, Illinois; Eastern Virginia Medical School, Norfolk, Virginia; Perleman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Cleveland Clinic, Cleveland, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; Attia Medical, San Diego, California; Northwestern University, Chicago, Illinois; Ochsner Health System, New Orleans, Louisiana; University of Texas Health Science Center at Houston, Houston, Texas; Columbia University, New York, New York; AbbVie Inc, North Chicago, Illinois; SUNY Downstate Health Science University, Brooklyn, New York; Mercy Health, Cincinnati, Ohio; and Thomas Jefferson University, Philadelphia, Pennsylvania.
• Obstet Gynecol. 2020 Jun 1; 135 (6): 1313-1326.

ObjectiveTo 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.MethodsElaris 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.ResultsFrom 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])}.ConclusionUp 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 RegistrationClinicalTrials.gov, NCT02925494.Funding SourceAbbVie Inc funded this study.

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