{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T05:57:53Z","timestamp":1790575073704,"version":"4.1.0"},"reference-count":41,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100013671","name":"Sun Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013671","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2026,10]]},"abstract":"ABSTRACT<\/jats:title>\n \n Objective<\/jats:title>\n To compare the efficacy, safety and tolerability of elagolix with dienogest in women with moderate\u2010to\u2010severe endometriosis\u2010associated pain.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n A multicentre, double\u2010blind, double\u2010dummy, randomised, parallel\u2010group, active\u2010controlled, non\u2010inferiority phase III study.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Nineteen clinical centres across India.<\/jats:p>\n <\/jats:sec>\n \n Study Population<\/jats:title>\n Women (18\u201349\u2009years) diagnosed with endometriosis and experiencing moderate\u2010to\u2010severe pain.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Participants were randomised (1:1) to receive oral elagolix (150\u2009mg once daily) or dienogest (2\u2009mg once daily) for 24\u2009weeks.<\/jats:p>\n <\/jats:sec>\n \n Outcome Measures<\/jats:title>\n The primary outcome was change in endometriosis\u2010related pain (Numeric Rating Scale [NRS]) from baseline to Day 85. Secondary outcomes included changes in NRS (Day 169), dysmenorrhoea, non\u2010menstrual pelvic pain (NMPP) scores (Days 85 and 169), rescue medication use, patient global impression of change (PGIC), adverse events and bone mineral density.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 340 patients screened, 230 were randomised (115 per group). At Day 85, both arms showed similar reductions in NRS pain scores with a treatment difference of 0.04 (95% CI: \u22120.3, 0.37) [\n p<\/jats:italic>\n \u2009=\u20090.9747] demonstrating non\u2010inferiority as upper 95% CI was below pre\u2010specified margin of 1.5. At Day 169, both arms showed comparable improvements in overall pain, dysmenorrhoea and NMPP from baseline (\n p<\/jats:italic>\n \u2009=\u20090.9372,\n p<\/jats:italic>\n \u2009=\u20090.8884, and\n p<\/jats:italic>\n \u2009=\u20090.9616, respectively). Rescue medication use and PGIC were comparable between treatment arms. Adverse event incidence was similar (elagolix: 14.8%; dienogest: 19.1%), with no serious TEAEs or discontinuations. No significant bone mineral density changes were observed.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Elagolix demonstrated non\u2010inferiority to dienogest with an acceptable safety and tolerability profile, supporting its use in managing endometriosis\u2010associated pain.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov<\/jats:ext-link>\n identifier: CTRI\/2023\/01\/049292\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/1471-0528.70256","type":"journal-article","created":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T05:17:13Z","timestamp":1778563033000},"page":"2025-2034","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Elagolix Versus Dienogest for Treatment of Moderate\u2010to\u2010Severe Endometriosis Pain: A Phase\n III<\/scp>\n , Multicentric, Double\u2010Blind, Active\u2010Controlled, Non\u2010Inferiority Study"],"prefix":"10.1111","volume":"133","author":[{"given":"Sneha","family":"Bhoir","sequence":"first","affiliation":[{"name":"Department of Obsterics and Gynaecology KKasturi Medicare Pvt Ltd Thane India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaldhara","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Pagarav Hospital & ICU Gandhinagar India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tushar","family":"Palve","sequence":"additional","affiliation":[{"name":"Cama and Albless Hospital Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mrinal Kanti","family":"Dash","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Sparsh Hospital & Critical Care Pvt Ltd Bhubaneshwar India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sweety","family":"Saigal","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Brij Medical Centre Pvt Ltd Kanpur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gourisankar","family":"Kamilya","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Obstetrics IPGME&R and SSKM Hospital Kolkata India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shalini","family":"Srivastava","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Om Surgical Center & Maternity Home Varanasi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kartikbhai","family":"Savalia","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Priyadarshani Nursing Home Virar India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanusree","family":"Gupta","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Udyan Health Care Pvt Ltd Lucknow India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepa","family":"Choudhary","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology SMS Hospital Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manohar","family":"Rangaswamy","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Mandya Institute of Medical Sciences Mandya India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidya V","family":"Bhatt","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Radhakrishna Multispeciality Hospital and IVF Center Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neena","family":"Gupta","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology GSVM Medical College Kanpur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malathi","family":"Ponnuru","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology Modern Government Maternity Hospital Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parul","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology SVP Hospital, Smt NHL Medical College and SVP Institute of Medical Sciences & Research Ahmedabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Apurva","family":"Shetty","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti","family":"Saha","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reshma","family":"Quadros","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sucheta","family":"Pandit","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-8690-3302","authenticated-orcid":false,"given":"Dipak","family":"Patil","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piyush","family":"Patel","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pravin","family":"Ghadge","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lalit","family":"Lakhwani","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suyog","family":"Mehta","sequence":"additional","affiliation":[{"name":"Sun Pharma Laboratories Limited, India Clinical Research Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadhana","family":"Joglekar","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries Limited Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,11]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-050844"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms221910554"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.18108"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/GRF.0000000000000292"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20153822"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1242991"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms24086992"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.18585\/inabj.v15i1.2114"},{"key":"e_1_2_13_10_1","first-page":"51","article-title":"Progesterone Resistance in Endometriosis","volume":"81","author":"Poorasamy J.","year":"2022","journal-title":"EMJ Reproductive Health"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.13156"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dez074"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-015-3641-1"},{"key":"e_1_2_13_14_1","volume-title":"Key Practice Points on Endometriosis","author":"Palshetkar N.","year":"2022"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-021-01545-5"},{"key":"e_1_2_13_16_1","article-title":"Good Clinical Practice Recommendations (GCPR): Updates in Endometriosis","author":"Committee E.","year":"2024","journal-title":"Management"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-016-4184-9"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1089\/whr.2022.0051"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm8006454"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.22381"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-019-00840-7"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2017.05.004"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700089"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aen103"},{"key":"e_1_2_13_25_1","first-page":"247","article-title":"MedDRA and Pharmacovigilance: A Complex and Little\u2010Evaluated Tool","volume":"25","year":"2016","journal-title":"Prescrire International"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/dmu046"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003461"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpain.2003.09.004"},{"key":"e_1_2_13_29_1","unstructured":"T.Beaumont \u201cEffect of Physiotherapy\u2010Led Group Therapy on Pain Reporting and Quality of Life in Women With Chronic Pelvic Pain [Trial Registration] \u201d Australian and New Zealand Clinical Trials Registry; ACTRN12619000316101. Prospectively registered 28 Feb 2019 accessed January 19 2026 https:\/\/anzctr.org.au\/trial\/registration\/trialreview.aspx?actrn=12619000316101."},{"key":"e_1_2_13_30_1","article-title":"Gonadotropin\u2010Releasing Hormone (GnRH)\/GnRH Receptors and Their Role in the Treatment of Endometriosis","volume":"15","author":"Resta C.","year":"2023","journal-title":"Cureus"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.5152\/jtgga.2013.52385"},{"key":"e_1_2_13_32_1","doi-asserted-by":"publisher","DOI":"10.1530\/RAF-22-0091"},{"key":"e_1_2_13_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/rmb2.12588"},{"key":"e_1_2_13_34_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002675"},{"key":"e_1_2_13_35_1","doi-asserted-by":"publisher","DOI":"10.1177\/1933719114549848"},{"key":"e_1_2_13_36_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-024-00767-1"},{"key":"e_1_2_13_37_1","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2019.8096"},{"key":"e_1_2_13_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2012.05.012"},{"key":"e_1_2_13_39_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1438.2006.00533.x"},{"key":"e_1_2_13_40_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2025.1552185"},{"key":"e_1_2_13_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jogc.2021.08.013"},{"key":"e_1_2_13_42_1","doi-asserted-by":"publisher","DOI":"10.1159\/000530896"}],"container-title":["BJOG: An International Journal of Obstetrics & Gynaecology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1471-0528.70256","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1471-0528.70256","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1471-0528.70256","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T05:54:46Z","timestamp":1790574886000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/1471-0528.70256"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,11]]},"references-count":41,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1111\/1471-0528.70256"],"URL":"https:\/\/doi.org\/10.1111\/1471-0528.70256","archive":["Portico"],"relation":{},"ISSN":["1470-0328","1471-0528"],"issn-type":[{"value":"1470-0328","type":"print"},{"value":"1471-0528","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,11]]},"assertion":[{"value":"2025-09-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}