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: Bruce Carr, W Paul Dmowski, Chris O'Brien, Ping Jiang, Joshua Burke, Roland Jimenez, Elizabeth Garner, Kristof Chwalisz
• Journal: Reproductive sciences (Thousand Oaks, Calif.) (Reprod Sci) Vol. 21 Issue 11 Pg. 1341-51 (Nov 2014) ISSN: 1933-7205 [Electronic] United States
• PMID: 25249568 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2014.

Chemical References

• Delayed-Action Preparations
• Hormone Antagonists
• Hydrocarbons, Fluorinated
• Pyrimidines
• Gonadotropin-Releasing Hormone
• elagolix
• Medroxyprogesterone

Topics

• Absorptiometry, Photon
• Administration, Oral
• Adult
• Bone Density (drug effects)
• Delayed-Action Preparations
• Endometriosis (complications, diagnosis, drug therapy, metabolism)
• Female
• Gonadotropin-Releasing Hormone (antagonists & inhibitors, metabolism)
• Hormone Antagonists (administration & dosage, adverse effects)
• Humans
• Hydrocarbons, Fluorinated (administration & dosage, adverse effects)
• Injections, Subcutaneous
• Medroxyprogesterone (administration & dosage, adverse effects)
• Pain Measurement
• Pelvic Pain (diagnosis, drug therapy, etiology)
• Pyrimidines (administration & dosage, adverse effects)
• Texas
• Time Factors
• Treatment Outcome
• United States