@article{d96a8799921e418b8093fafc6ea4a75c,
title = "Elagolix Treatment for Up to 12 Months in Women with Heavy Menstrual Bleeding and Uterine Leiomyomas",
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.",
author = "Simon, {James A.} and Ayman Al-Hendy and Archer, {David F.} and Barnhart, {Kurt T.} and Bradley, {Linda D.} and Carr, {Bruce R.} and Thomas Dayspring and Feinberg, {Eve C.} and Veronica Gillispie and Sandra Hurtado and Jinhee Kim and Ran Liu and Owens, {Charlotte D.} and Ozgul Muneyyirci-Delale and Alice Wang and Watts, {Nelson B.} and Schlaff, {William D.}",
note = "Funding Information: Financial Disclosure James A. Simon has served or is currently serving as a consultant to or on the advisory boards of: AbbVie, Inc, Allergan, Plc, AMAG Pharmaceuticals, Inc, Amgen, Ascend Therapeutics, Bayer HealthCare Pharmaceuticals Inc, CEEK Enterprises, LLC, Covance Inc, Dare' Bioscience, Duchesnay USA, Hologic Inc, KaNDy/NeRRe Therapeutics Ltd, Mitsubishi Tanabe Pharma Development America, Inc, ObsEva SA, Palatin Technologies, Sanofi S.A., Shionogi Inc, Sprout Inc, and TherapeuticsMD. He has also served or is currently serving on the speaker's bureaus of: AbbVie Inc, AMAG Pharmaceuticals, Inc, Duchesnay USA, Novo Nordisk, Shionogi Inc, TherapeuticsMD. He has received or is currently receiving grant/research support from: AbbVie, Inc, Allergan, Plc, Agile Therapeutics, Bayer Healthcare LLC., Endoceutics, Inc, GTx, Inc, Ipsen, Myovant Sciences, New England Research Institute, Inc, ObsEva SA, Palatin Technologies, Symbio Research, Inc, TherapeuticsMD, and Viveve Medical. He is a stockholder in Sermonix Pharmaceuticals. Ayman Al-Hendy has provided consulting services to AbbVie, Allergan, Bayer, Myovant, MD Stem Cells, and he is grant funded by the National Institute of Health for fibroid-related research (R01 ES 028615-01, R01 HD 087417, R01 HD 094378, R01 HD 094380, 5U54 MD 007602-32, R01 HD 100367-01). In addition, he holds a patent for Methods for novel diagnostics and therapeutics for uterine sarcoma (US Pat No. 9,790,562 B2). He was affiliated with Augusta University at the time that the study was completed. David F. Archer has received research support from AbbVie, TherapeuticsMD, Bayer HealthCare, Endoceutics, Glenmark, Shionogi, Symbio and Radius and compensation from AbbVie, TherapeuticsMD, Bayer HealthCare, Endoceutics, Agile Pharmaceuticals, Exeltis/CHEMO France, and TEVA/HR Pharma for consulting. Kurt T. Barnhart has served as a consultant to AbbVie and Bayer and served on the AbbVie Data and Safety Monitoring Committee. Linda D. Bradley has served as a scientific advisor for AbbVie, Bayer, Allergan, Boston Scientific, Medtronics, Karl Storz, and has received research support from Bayer and royalties from UpToDate, Elsevier, and Wolters Kluwer. Bruce R. Carr has received research support from AbbVie and Syneract, Inc (M360-L102) and served on the Repros Therapeutics Data and Safety Monitoring Board. Thomas Dayspring served as Chief Academic Officer for True Health Diagnostics and a consultant for AbbVie; affiliated with True Health Diagnostics at the time that the study was completed. Eve C. Feinberg has served as a consultant to AbbVie, Natera, and CooperSurgical and served on the AbbVie Data and Safety Monitoring Committee. Veronica Gillispie has served as a study investigator for AbbVie and has served as a consultant to AbbVie. Sandra Hurtado has served as consultant for AbbVie, served on the speaker bureau for AbbVie, Merck, and Bayer, and served as an investigator for AbbVie, Allergan, Amgen, Bayer, Femasys, Ferring, Myovant, Obseva and Therapeutics MD. JinHee Kim has served as a consultant to AbbVie and is a member of the Board of Directors for AAGL. Ran Liu is an AbbVie employee and holds stock or stock options. Charlotte D. Owens is an AbbVie employee and holds stock or stock options. Ozgul Muneyyirci-Delale is a study investigator for AbbVie, Bayer, ObsEva, and Ferring. Alice Wang is an AbbVie employee and holds stock or stock options. Nelson B. Watts has received compensation from Amgen and Radius for speaker honoraria, and from AbbVie, Amgen, Janssen, Radius, and Sanofi for consulting. William D. Schlaff has served as a consultant to AbbVie and has received research support from AbbVie. Publisher Copyright: {\textcopyright} 2020 Lippincott Williams and Wilkins. All rights reserved.",
year = "2020",
month = jun,
day = "1",
doi = "10.1097/AOG.0000000000003869",
language = "English (US)",
volume = "135",
pages = "1313--1326",
journal = "Obstetrics and gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "6",
}