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Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis: effects on bone mineral density.

Author(s): Carr B(1), Dmowski WP(2), O'Brien C(3), Jiang P(4), Burke J(3), Jimenez R(3), Garner E(4), Chwalisz K(4).

Affiliation(s): Author information: (1)Department of Obstetrics and Gynecology, Reproductive Endocrinology & Infertility Fellowship Program, University of Texas Southwestern Medical Center, Dallas, TX, USA bruce.carr@utsouthwestern.edu. (2)Institute for the Study and Treatment of Endometriosis, Oak Brook, IL, USA. (3)Neurocrine Biosciences, Inc, San Diego, CA USA. (4)AbbVie Inc, North Chicago, IL, USA.

Publication date & source: 2014, Reprod Sci. , 21(11):1341-51

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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