title: Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis: effects on bone mineral density.
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.
authors.affiliation: Department of Obstetrics and Gynecology, Reproductive Endocrinology & Infertility Fellowship Program, University of Texas Southwestern Medical Center, Dallas, TX, USA bruce.carr@utsouthwestern.edu.
authors.forename: Bruce
authors.initials: B
authors.lastname: Carr
authors.affiliation: Institute for the Study and Treatment of Endometriosis, Oak Brook, IL, USA.
authors.forename: W Paul
authors.initials: WP
authors.lastname: Dmowski
authors.affiliation: Neurocrine Biosciences, Inc, San Diego, CA USA.
authors.forename: Chris
authors.initials: C
authors.lastname: O'Brien
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Jiang
authors.affiliation: Neurocrine Biosciences, Inc, San Diego, CA USA.
authors.forename: Joshua
authors.initials: J
authors.lastname: Burke
authors.affiliation: Neurocrine Biosciences, Inc, San Diego, CA USA.
authors.forename: Roland
authors.initials: R
authors.lastname: Jimenez
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Garner
authors.affiliation: AbbVie Inc, North Chicago, IL, USA.
authors.forename: Kristof
authors.initials: K
authors.lastname: Chwalisz
mesh_terms: D015502:Absorptiometry, Photon; D000284:Administration, Oral; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D003692:Delayed-Action Preparations; D004715:Endometriosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors* / Q000378:metabolism; D006727:Hormone Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage* / Q000009:adverse effects; D007279:Injections, Subcutaneous; D008525:Medroxyprogesterone / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D017699:Pelvic Pain / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D003692:Delayed-Action Preparations; D006727:Hormone Antagonists; D006845:Hydrocarbons, Fluorinated; D011743:Pyrimidines; D007987:Gonadotropin-Releasing Hormone; C539351:elagolix; D008525:Medroxyprogesterone
keywords: GnRH antagonists; elagolix; endometriosis; pelvic pain