{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T02:52:50Z","timestamp":1790736770707,"version":"4.1.0"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,6,16]],"date-time":"2021-06-16T00:00:00Z","timestamp":1623801600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,16]],"date-time":"2021-06-16T00:00:00Z","timestamp":1623801600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Women's Health"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were pooled from two 6-month, placebo-controlled, phase 3 studies (Elaris Endometriosis [EM]-I and II) in which 2 doses of elagolix were evaluated (150\u00a0mg once daily and 200\u00a0mg twice daily). Pooled data from\u2009&gt;\u20091600 women, aged 18\u201349, were used to evaluate the efficacy of elagolix and health-related quality of life (HRQoL) in prespecified subgroups of women with various baseline characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 1686 women treated, 1285 (76.2%) completed the studies. The percentages of women with clinically meaningful reductions in dysmenorrhea and NMPP were generally consistent by subgroup. Significant treatment by subgroup interaction was demonstrated for dysmenorrhea response in baseline analgesic use (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.01) and previous history of pregnancy (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05) subgroups, and for NMPP response in the baseline NMPP score (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05) and history of pregnancy (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05) subgroups. Patient-reported reduction in pain at month 3 was significant across all subgroups taking elagolix 200\u00a0mg BID, and significant across most subgroups with elagolix 150\u00a0mg QD. Women across subgroups experienced improvement within each domain of the Endometriosis Health Profile-30 (EHP-30), although significant treatment by subgroup interactions were observed in several categories.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Elagolix was effective in reducing dysmenorrhea and NMPP, and improving HRQoL, compared with placebo across numerous subgroups of women with various baseline characteristics, covering a broad segment of the endometriosis disease and patient types.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Clinical trial registration<\/jats:italic>\n                      :\u00a0ClinicalTrials.gov:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01620528\">https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01620528<\/jats:ext-link>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01931670\">https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01931670<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12905-021-01385-3","type":"journal-article","created":{"date-parts":[[2021,6,16]],"date-time":"2021-06-16T10:02:54Z","timestamp":1623837774000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients"],"prefix":"10.1186","volume":"21","author":[{"given":"Mauricio S.","family":"Abrao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Surrey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael C.","family":"Snabes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horia","family":"Ijacu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh S.","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,16]]},"reference":[{"issue":"25","key":"1385_CR1","doi-asserted-by":"publisher","first-page":"2389","DOI":"10.1056\/NEJMcp1000274","volume":"362","author":"LC Giudice","year":"2010","unstructured":"Giudice LC. 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These studies were conducted in accordance with the International Council for Harmonisation, Good Clinical Practice guidelines, the ethical concepts of the Declaration of Helsinki, and\/or all applicable federal and local regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"This manuscript does not show or report personal data such as individual details or images; therefore, consent for publication is not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MSA reports roles as Vice President of the American Association of Gynecologic Laparoscopists and Editor-in-Chief of the <i>Journal of Endometriosis and Pelvic Pain Diseases<\/i>. ES has received research support from AbbVie, has served on medical advisory boards for AbbVie and Dot Laboratories, and has been a member of the speakers\u2019 bureau for AbbVie and Ferring Laboratories. HST has received research support from AbbVie, DotLab, and Pfizer and has served as a consultant for AbbVie. MCS, KG, HW, and HI are AbbVie employees and hold stock or own stock options.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"246"}}