{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:16:20Z","timestamp":1792800980714,"version":"4.5.0"},"reference-count":11,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"ASKA Pharmaceutical Co., Ltd.","id":[{"id":"https:\/\/ror.org\/05sjgam45","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n The oral gonadotropin-releasing hormone antagonist relugolix, which temporarily stops menstruation, is used to treat heavy menstrual bleeding, pelvic pressure, and low back pain in women with uterine fibroids. Treatment can also help women recover from low hemoglobin levels and possibly shrink the fibroids. However, evidence of preoperative use of relugolix before laparoscopic myomectomy is limited. Nevertheless, the treatment could reduce interoperative blood loss, decrease the risk of developing postoperative anemia, and shorten the operative time. Thus, we aim to test whether 12-week preoperative treatment with relugolix (40\u00a0mg orally, once daily) is similar to or not worse than leuprorelin (one injection every 4\u00a0weeks) to reduce intraoperative blood loss.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Efficacy and safety of preoperative administration of drugs will be studied in a multi-center, randomized, open-label, parallel-group, noninferiority trial enrolling premenopausal women\u2009\u2265\u200920\u00a0years of age, diagnosed with uterine fibroids and scheduled for laparoscopic myomectomy. Participants (\n n<\/jats:italic>\n \u2009=\u200980) will be recruited in the clinical setting of participating institutions. The minimization method (predefined factors: presence or absence of fibroids\u2009\u2265\u20099\u00a0cm and the International Federation of Gynecology and Obstetrics [FIGO] type 1\u20135 fibroids) with randomization is used in a 1:1 allocation. Relugolix is a 40-mg oral tablet taken once a day before a meal, for 12\u00a0weeks, up to the day before surgery. Leuprorelin is a 1.88\u00a0mg, or 3.75\u00a0mg subcutaneous injection, given in three 4-week intervals during patient visits before the surgery. For the primary outcome measure of intraoperative bleeding, the blood flow is collected from the body cavity, surgical sponges, and collection bag and measured in milliliters. Secondary outcome measures are hemoglobin levels, myoma size, other surgical outcomes, and quality-of-life questionnaire responses (Kupperman Konenki Shogai Index and Uterine Fibroid Symptoms\u2014Quality of Life).\n <\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n Real-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n jRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials (\n https:\/\/jrct.niph.go.jp<\/jats:ext-link>\n ).\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-024-08170-1","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T21:02:17Z","timestamp":1716584537000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy in premenopausal women, diagnosed with uterine fibroids: protocol for a randomized controlled study (MyLacR study)"],"prefix":"10.1186","volume":"25","author":[{"given":"Mari","family":"Kitade","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Kumakiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Kobori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisuke","family":"Murakami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,5,24]]},"reference":[{"key":"8170_CR1","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1080\/13697137.2018.1549216","volume":"22","author":"J Donnez","year":"2019","unstructured":"Donnez J, Courtoy GE, Dolmans M-M. Fibroid management in premenopausal women. Climacteric. 2019;22:27\u201333. Taylor & Francis.","journal-title":"Climacteric"},{"key":"8170_CR2","doi-asserted-by":"publisher","first-page":"615","DOI":"10.1016\/j.bpobgyn.2008.01.008","volume":"22","author":"S Gupta","year":"2008","unstructured":"Gupta S, Jose J, Manyonda I. Clinical presentation of fibroids. Best Pract Res Clin Obstet Gynaecol. 2008;22:615\u201326.","journal-title":"Best Pract Res Clin Obstet Gynaecol"},{"key":"8170_CR3","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1055\/s-0037-1607264","volume":"35","author":"A Al-Hendy","year":"2017","unstructured":"Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473\u201380.","journal-title":"Semin Reprod Med"},{"key":"8170_CR4","doi-asserted-by":"publisher","first-page":"1359","DOI":"10.1089\/jwh.2018.7076","volume":"27","author":"EE Marsh","year":"2018","unstructured":"Marsh EE, Al-Hendy A, Kappus D, Galitsky A, Stewart EA, Kerolous M. Burden, prevalence, and treatment of uterine fibroids: a survey of U.S. women. J Womens Health (Larchmt). 2018;27:1359\u201367.","journal-title":"J Womens Health (Larchmt)"},{"key":"8170_CR5","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1016\/j.jpsychores.2014.12.016","volume":"78","author":"MS Ghant","year":"2015","unstructured":"Ghant MS, Sengoba KS, Recht H, Cameron KA, Lawson AK, Marsh EE. Beyond the physical: a qualitative assessment of the burden of symptomatic uterine fibroids on women\u2019s emotional and psychosocial health. J Psychosom Res. 2015;78:499\u2013503.","journal-title":"J Psychosom Res"},{"key":"8170_CR6","unstructured":"Editorial Board, Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy. Guidelines for Endoscopic Surgery in Obstetrics and Gynecology (in Japanese). 2019th ed. Kanehara Publishing Company; Available from: https:\/\/www.kanehara-shuppan.co.jp\/books\/detail.html?isbn=9784307301404."},{"key":"8170_CR7","first-page":"CD004638","volume":"2014","author":"P BhaveChittawar","year":"2014","unstructured":"BhaveChittawar P, Franik S, Pouwer AW, Farquhar C. Minimally invasive surgical techniques versus open myomectomy for uterine fibroids. Cochrane Database Syst Rev. 2014;2014:CD004638.","journal-title":"Cochrane Database Syst Rev."},{"key":"8170_CR8","first-page":"CD000547","volume":"11","author":"A Lethaby","year":"2017","unstructured":"Lethaby A, Puscasiu L, Vollenhoven B. Preoperative medical therapy before surgery for uterine fibroids. Cochrane Database Syst Rev. 2017;11:CD000547.","journal-title":"Cochrane Database Syst Rev."},{"key":"8170_CR9","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1016\/j.jmig.2011.02.010","volume":"18","author":"I Chen","year":"2011","unstructured":"Chen I, Motan T, Kiddoo D. Gonadotropin-releasing hormone agonist in laparoscopic myomectomy: systematic review and meta-analysis of randomized controlled trials. J Minim Invasive Gynecol. 2011;18:303\u20139.","journal-title":"J Minim Invasive Gynecol"},{"key":"8170_CR10","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1097\/AOG.0000000000003141","volume":"133","author":"Y Osuga","year":"2019","unstructured":"Osuga Y, Enya K, Kudou K, Tanimoto M, Hoshiai H. Oral gonadotropin-releasing hormone antagonist relugolix compared with leuprorelin injections for uterine leiomyomas: a randomized controlled trial. Obstet Gynecol. 2019;133:423\u201333.","journal-title":"Obstet Gynecol"},{"key":"8170_CR11","unstructured":"Relumina tablets 453 40 mg package insert, version 2, 2023 (in Japanese). Available from: https:\/\/www.info.pmda.go.jp\/go\/pack\/2499013F1027_2_06\/."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08170-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08170-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08170-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T21:04:42Z","timestamp":1716584682000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08170-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,24]]},"references-count":11,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8170"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08170-1","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,24]]},"assertion":[{"value":"21 November 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 May 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 May 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The Chairman of the Clinical Research Review Committee of Juntendo University certified on 2 August 2022, 6 January 2023, 8 May 2023, and 1 August 2023, the appropriateness of the research and change in the implementation plan submitted on 15 July 2022 for jRCT s031210564 registered on 19 January 2022 in the Japan Registry of Clinical Trials (\n \n ). This protocol, Explanatory Document and Consent Form for Clinical Research, and all other documents about this study shall be reviewed and approved by the Certified Review Board during the planning and implementation of the study. In addition, the chief investigator shall submit safety and progress reports to directors of the implementing medical institutions each year (starting from the date of submitting the implementation plan to the MHLW) and make periodic reports to the Certified Review Board, as specified in the implementation plan.All persons involved in this research will conduct the study following the Declaration of Helsinki of the World Medical Association, the Clinical Research Act, its implementing regulations, and other relevant notices with which all medical research involving human subjects must comply. Furthermore, investigators of all participating medical institutions will obtain written informed consent from participants in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable\u2014no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the study results. Informed consent materials are available from the corresponding author, Professor Mari Kitade, email: kitade@juntendo.ac.jp.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"MK, JK, and HK received honoraria as a speaker and consultant fee from ASKA Pharmaceutical Co., Ltd. KM received honoraria as a speaker from ASKA Pharmaceutical Co., Ltd.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"343"}}