{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T01:25:22Z","timestamp":1778203522408,"version":"3.51.4"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2020,9,12]],"date-time":"2020-09-12T00:00:00Z","timestamp":1599868800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"},{"start":{"date-parts":[[2020,9,12]],"date-time":"2020-09-12T00:00:00Z","timestamp":1599868800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"name":"sponsored the study"},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jsm.jsexmed.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>We evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18\u201349 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150\u00a0mg once daily, or elagolix 200\u00a0mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0\u20133 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable\/decreased analgesic use.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Outcomes<\/jats:title>\n                  <jats:p>Dyspareunia response impact on EHP-30 scores was determined at 3 and 6\u00a0months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Analysis included 1,368 women with a mean age of 32.2\u00a0years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness:\u00a0\u221217.8 and\u00a0\u221218.5; emotional well-being:\u00a0\u221210.0 and\u00a0\u221210.4; pain:\u00a0\u221215.3 and\u00a0\u221215.7; self-image:\u00a0\u221211.4 and\u00a0\u221212.8; social support:\u00a0\u221214.3 and\u00a0\u221214.0; and sexual intercourse:\u00a0\u221218.1 and\u00a0\u221219.7; all P\u00a0&amp;lt;\u00a0.0001).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Implications<\/jats:title>\n                  <jats:p>Dyspareunia improvements are associated with both personal and psychological benefits.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Strengths &amp; Limitations<\/jats:title>\n                  <jats:p>This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Clinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1016\/j.jsxm.2020.08.002","type":"journal-article","created":{"date-parts":[[2020,9,12]],"date-time":"2020-09-12T07:26:33Z","timestamp":1599895593000},"page":"2427-2433","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":13,"title":["Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix"],"prefix":"10.1093","volume":"17","author":[{"given":"Sanjay K.","family":"Agarwal","sequence":"first","affiliation":[{"name":"Center for Endometriosis Research and Treatment , La Jolla, CA , USA"},{"name":"University of California, San Diego , La Jolla, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmed M.","family":"Soliman","sequence":"additional","affiliation":[{"name":"Health Economics and Outcomes Research , North Chicago, IL , USA"},{"name":"AbbVie Inc , North Chicago, IL , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robin M.","family":"Pokrzywinski","sequence":"additional","affiliation":[{"name":"Patient-Centered Research , Bethesda, MD , USA"},{"name":"Evidera , Bethesda, MD , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael C.","family":"Snabes","sequence":"additional","affiliation":[{"name":"Global Pharmaceutical Research and Development , North Chicago, IL , USA"},{"name":"AbbVie Inc , North Chicago, IL , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin S.","family":"Coyne","sequence":"additional","affiliation":[{"name":"Patient-Centered Research , Bethesda, MD , USA"},{"name":"Evidera , Bethesda, MD , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2020,9,12]]},"reference":[{"key":"2023011111070733700_bib1","doi-asserted-by":"crossref","first-page":"1552","DOI":"10.1093\/humrep\/det050","article-title":"Consensus on current management of endometriosis","volume":"28","author":"Johnson","year":"2013","journal-title":"Hum Reprod"},{"key":"2023011111070733700_bib2","first-page":"3","article-title":"Creating solutions in endometriosis: global collaboration through the World Endometriosis Research Foundation","volume":"2","author":"Adamson","year":"2010","journal-title":"J\u00a0Endometr"},{"key":"2023011111070733700_bib3","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1080\/0167482X.2017.1289512","article-title":"The burden of endometriosis symptoms on health-related quality of life in women in the United States: a cross-sectional study","volume":"38","author":"Soliman","year":"2017","journal-title":"J\u00a0Psychosom Obstet Gynaecol"},{"key":"2023011111070733700_bib4","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1016\/j.fertnstert.2011.05.090","article-title":"Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries","volume":"96","author":"Nnoaham","year":"2011","journal-title":"Fertil Steril"},{"key":"2023011111070733700_bib5","first-page":"745","article-title":"The effect of endometriosis symptoms on absenteeism and presenteeism in the workplace and at home","volume":"23","author":"Soliman","year":"2017","journal-title":"J\u00a0Manag Care Spec Pharm"},{"key":"2023011111070733700_bib6","doi-asserted-by":"crossref","first-page":"2424","DOI":"10.1016\/j.fertnstert.2009.09.017","article-title":"Patients' report on how endometriosis affects health, work, and daily life","volume":"93","author":"Fourquet","year":"2010","journal-title":"Fertil Steril"},{"key":"2023011111070733700_bib7","first-page":"73","article-title":"Female perspectives on endometriosis: findings from the uterine bleeding and pain women\u2019s research study","volume":"3","author":"Bernuit","year":"2011","journal-title":"J\u00a0Endometr"},{"key":"2023011111070733700_bib8","doi-asserted-by":"crossref","first-page":"573","DOI":"10.1016\/j.fertnstert.2004.07.973","article-title":"Quality of sex life in women with endometriosis and deep dyspareunia","volume":"83","author":"Ferrero","year":"2005","journal-title":"Fertil Steril"},{"key":"2023011111070733700_bib9","doi-asserted-by":"crossref","first-page":"114","DOI":"10.1177\/1933719110382921","article-title":"Priorities for endometriosis research: a proposed focus on deep dyspareunia","volume":"18","author":"Vercellini","year":"2011","journal-title":"Reprod Sci"},{"key":"2023011111070733700_bib10","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1186\/1472-6874-14-123","article-title":"Impact of endometriosis on women's lives: a qualitative study","volume":"14","author":"Moradi","year":"2014","journal-title":"BMC Womens Health"},{"key":"2023011111070733700_bib11","article-title":"OrilissaTM [package insert]","year":"2019"},{"key":"2023011111070733700_bib12","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1056\/NEJMoa1700089","article-title":"Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist","volume":"377","author":"Taylor","year":"2017","journal-title":"N\u00a0Engl J Med"},{"key":"2023011111070733700_bib13","doi-asserted-by":"crossref","first-page":"497","DOI":"10.2217\/pmt-2019-0010","article-title":"Clinical evaluation of the oral gonadotropin-releasing hormone-antagonist elagolix for the management of endometriosis-associated pain","volume":"9","author":"Taylor","year":"2019","journal-title":"Pain Manag"},{"key":"2023011111070733700_bib14","first-page":"258","article-title":"Development of an endometriosis quality-of-life instrument: the endometriosis health profile-30","volume":"98","author":"Jones","year":"2001","journal-title":"Obstet Gynecol"},{"key":"2023011111070733700_bib15","doi-asserted-by":"crossref","first-page":"1567","DOI":"10.1177\/1933719118789509","article-title":"Development and validation of the endometriosis daily pain impact diary items to assess dysmenorrhea and nonmenstrual pelvic pain","volume":"25","author":"Wyrwich","year":"2018","journal-title":"Reprod Sci"},{"key":"2023011111070733700_bib16","doi-asserted-by":"crossref","first-page":"592e1","DOI":"10.1016\/j.ajog.2019.11.1255","article-title":"Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials","volume":"222","author":"Pokrzywinski","year":"2020","journal-title":"Am J Obstet Gynecol"},{"key":"2023011111070733700_bib17","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1089\/jwh.2019.7788","article-title":"Responsiveness evaluation and recommendation for responder thresholds for endometriosis health profile-30: analysis of two phase III clinical trials","volume":"29","author":"Pokrzywinski","year":"2019","journal-title":"J\u00a0Womens Health (Larchmt)"},{"key":"2023011111070733700_bib18","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1093\/humupd\/dmt027","article-title":"The social and psychological impact of endometriosis on women's lives: a critical narrative review","volume":"19","author":"Culley","year":"2013","journal-title":"Hum Reprod Update"},{"key":"2023011111070733700_bib19","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1146\/annurev-pharmtox-010818-021542","article-title":"The placebo effect in pain therapies","volume":"59","author":"Colloca","year":"2019","journal-title":"Annu Rev Pharmacol Toxicol"}],"container-title":["The Journal of Sexual Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1743609520308407?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1743609520308407?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/academic.oup.com\/jsm\/article-pdf\/17\/12\/2427\/48525867\/jsm_17_12_2427.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jsm\/article-pdf\/17\/12\/2427\/48525867\/jsm_17_12_2427.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T14:47:51Z","timestamp":1675954071000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jsm\/article\/17\/12\/2427\/6973545"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,12]]},"references-count":19,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2020,9,12]]},"published-print":{"date-parts":[[2020,12,1]]}},"URL":"https:\/\/doi.org\/10.1016\/j.jsxm.2020.08.002","relation":{},"ISSN":["1743-6109","1743-6095"],"issn-type":[{"value":"1743-6109","type":"electronic"},{"value":"1743-6095","type":"print"}],"subject":[],"published-other":{"date-parts":[[2020,12]]},"published":{"date-parts":[[2020,9,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix","name":"articletitle","label":"Article Title"},{"value":"The Journal of Sexual Medicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jsxm.2020.08.002","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 International Society for Sexual Medicine. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}