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Elagolix, an Oral GnRH Antagonist, Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis: Effects on Bone Mineral Density

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Abstract

This randomized double-blind study, with 24-week treatment and 24-week posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on bone mineral density (BMD), in women with endometriosis-associated pain (n = 252). All treatments induced minimal mean changes from baseline in BMD at week 24 (elagolix 150 mg: −0.11%/−0.47%, elagolix 75 mg: −1.29%/−1.2%, and DMPA-SC: 0.99%/−1.29% in the spine and total hip, respectively), with similar or less changes at week 48 (posttreatment). Elagolix was associated with improvements in endometriosis-associated pain, assessed with composite pelvic signs and symptoms score (CPSSS) and visual analogue scale, including statistical noninferiority to DMPA-SC in dysmenorrhea and nonmenstrual pelvic pain components of the CPSSS. The most common adverse events (AEs) in elagolix groups were headache, nausea, and nasopharyngitis, whereas the most common AEs in the DMPA-SC group were headache, nausea, upper respiratory tract infection, and mood swings. This study showed that similar to DMPA-SC, elagolix treatment had minimal impact on BMD over a 24-week period and demonstrated similar efficacy on endometriosis-associated pain.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Reproductive Endocrinology & Infertility Fellowship Program, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, 75390, Dallas, TX, USA

    Bruce Carr MD

  2. Institute for the Study and Treatment of Endometriosis, Oak Brook, IL, USA

    W. Paul Dmowski MD

  3. Neurocrine Biosciences, Inc, San Diego, CA, USA

    Chris O’Brien MD, Joshua Burke MS & Roland Jimenez BS

  4. AbbVie Inc, North Chicago, IL, USA

    Ping Jiang MS, Elizabeth Garner MD, MPH & Kristof Chwalisz MD, PhD

Authors
  1. Bruce Carr MD
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  2. W. Paul Dmowski MD
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  3. Chris O’Brien MD
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  4. Ping Jiang MS
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  5. Joshua Burke MS
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  6. Roland Jimenez BS
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  7. Elizabeth Garner MD, MPH
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  8. Kristof Chwalisz MD, PhD
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Correspondence to Bruce Carr MD.

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Carr, B., Dmowski, W.P., O’Brien, C. et al. Elagolix, an Oral GnRH Antagonist, Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis: Effects on Bone Mineral Density. Reprod. Sci. 21, 1341–1351 (2014). https://doi.org/10.1177/1933719114549848

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  • DOI: https://doi.org/10.1177/1933719114549848

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