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Sci."],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Several clinical trials in women with endometriosis demonstrated that dienogest reduces endometrial lesions and improves health-related quality of life (HRQoL). To assess HRQoL in dienogest-treated patients in real-world setting, we conducted a prospective, non-interventional study in 6 Asian countries. Women aged \u226518\u00a0years with clinical or surgical diagnosis of endometriosis, presence of endometriosis-associated pelvic pain (EAPP) and initiating dienogest therapy were enrolled. The primary objective was to evaluate HRQoL using the Endometriosis Health Profile-30 (EHP-30) questionnaire. The secondary objectives included analysis of EAPP, satisfaction with dienogest, endometriosis symptoms and bleeding patterns. 887 patients started dienogest therapy. Scores for all EHP-30 scales improved with the largest mean changes at month 6 and 24 in scale pain (\u221228.9\u2009\u00b1\u200927.5 and\u2009\u2212\u200934\u2009\u00b1\u200928.4) and control and powerlessness (\u221223.7\u2009\u00b1\u200928.2 and\u2009\u2212\u200928.5\u2009\u00b1\u200926.2). Mean EAPP score change was \u22124.6\u2009\u00b1\u20093.0 for both month 6 and 24 assessments. EAPP decrease was similar in surgically and only clinically diagnosed patients. From baseline to month 24, rates of normal bleeding decreased (from 85.8% to 17.5%) while rates of amenorrhea increased (from 3.5% to 70.8%). Majority of patients and physicians were satisfied with dienogest. Over 80% of patients reported symptoms improvement. 39.9% of patients had drug-related treatment-emergent adverse events, including vaginal hemorrhage (10.4%), metrorrhagia (7.3%) and amenorrhea (6.4%). In conclusion, dienogest improves HRQoL and EAPP in the real-world setting in women with either clinical or surgical diagnosis of endometriosis. Dienogest might be a promising first-line treatment option for the long-term management of debilitating endometriosis-associated symptoms.<\/jats:p><jats:p>NCT02425462, 24 April 2015.<\/jats:p>","DOI":"10.1007\/s43032-021-00787-w","type":"journal-article","created":{"date-parts":[[2022,2,2]],"date-time":"2022-02-02T19:02:21Z","timestamp":1643828541000},"page":"1157-1169","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN"],"prefix":"10.1007","volume":"29","author":[{"given":"Kitirat","family":"Techatraisak","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andon","family":"Hestiantoro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruey","family":"Soon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Jesusa","family":"Banal-Silao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mee-Ran","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seok Ju","family":"Seong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syarief Thaufik","family":"Hidayat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"SoYoung","family":"Shin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6001-2079","authenticated-orcid":false,"given":"Byung Seok","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,2,2]]},"reference":[{"key":"787_CR1","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/1472-6874-12-9","volume":"12","author":"C Gerlinger","year":"2012","unstructured":"Gerlinger C, Faustmann T, Hassall JJ, Seitz C. 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All other authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}},{"value":"The Food and Drug Administration, Department of Health, Republic of the Philippines approved the study protocol and all relevant study documents prior to study start. Ethical approval was obtained from each participating site of the Philippines (St. Luke\u2019s Medical Center; University of the East Ramon Magsaysay Memorial Medical Center; University of Santo Tomas Hospital), Thailand (Faculty of Medicine Siriraj Hospital; Faculty of Medicine Vajra Hospital; Faculty of Medicine Chiang Mai University; Faculty of Medicine Ramathibodi Hospital, Mahidol University; Maharat Nakhon Ratchasima Hospital) and Korea (CHA Gangnam Medical Center, CHA University; Keimyung University Dongsan Hospital; ChungNam National University Hospital; Inha University Hospital; The Catholic University Of Korea, Seoul St. Mary\u2019s Hospital; Seoul National University Hospital; Korea University Anam Hospital Clinical Trial Center; Ajou University Hospital; Severance Hospital Clinical Trial Center; ChonNam National University Hospital; Pusan National University Yangsan Hospital; GangNam Severance Hospital). Centralized ethical approval for participating sites was obtained for Singapore (SingHealth), Malaysia (Ministry of Health) and Indonesia (Faculty of Medicine University of Indonesia).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All enrolled patients gave written informed consent prior to any study-related procedure.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}}]}}