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

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Elagolix treatment for endometriosis-associated pain demonstrated minimal impact on bone mineral density, comparable to DMPA-SC, while showing similar efficacy in pain reduction.

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This randomized, double-blind trial enrolled 252 women with endometriosis-associated pain and compared oral elagolix (150 mg once daily or 75 mg twice daily) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) over 24 weeks, followed by 24 weeks posttreatment. Across treatment and into follow-up, all groups showed minimal mean changes in bone mineral density at week 24 and similar or less changes at week 48, with elagolix causing small decreases while DMPA-SC showed slight increases at week 24. Elagolix also improved endometriosis-associated pain measured by CPSSS and a visual analogue scale, demonstrating statistical noninferiority to DMPA-SC for dysmenorrhea and the nonmenstrual pelvic pain component; the key caveat is the 24-week treatment duration, limiting conclusions about longer-term effects. This paper is centrally about endometriosis—an elagolix versus DMPA-SC comparison assessing endometriosis-associated pain efficacy and bone mineral density changes.

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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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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. Similar content being viewed by others

References

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Author information Authors and Affiliations Corresponding author Rights and permissions About this article Cite this article 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 Published: Issue date: DOI: https://doi.org/10.1177/1933719114549848

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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Bone Density Endometriosis Gonadotropin-Releasing Hormone Hormone Antagonists Hydrocarbons, Fluorinated Medroxyprogesterone Pyrimidines Absorptiometry, Photon Administration, Oral Adult Bone Density Delayed-Action Preparations Endometriosis Endometriosis Endometriosis Endometriosis Female Gonadotropin-Releasing Hormone Gonadotropin-Releasing Hormone Hormone Antagonists

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