{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T19:16:43Z","timestamp":1774379803801,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,6,9]],"date-time":"2021-06-09T00:00:00Z","timestamp":1623196800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Obstet and Gynaecol"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the efficacy and safety of long\u2010term intermittent administration of 10\u2010mg ulipristal acetate (UPA) for symptomatic uterine fibroids in Japanese women.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Open\u2010label, noncomparative study (Japan Primary Registries Network identifier: JapicCTI\u2010173737) conducted at 32 gynecological centers (November 2017\u2013December 2019). Premenopausal women diagnosed with uterine fibroids associated with heavy menstrual bleeding received three 12\u2010week courses of 10\u2010mg UPA once daily. Amenorrhea, fibroid volume, endometrial histology, and safety were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 155 patients enrolled, 140 received \u22651 dose of UPA and were analyzed. Across all courses, the rates of patients with amenorrhea for 35\u2009days were &gt;90%, and &gt;99% of patients achieved uterine bleeding normalization. Median time to amenorrhea after each course started was 4\u20135\u2009days; menstruation returned after treatment within a median of 25\u201327\u2009days. Mean changes in fibroid volume from baseline were \u221221.5%, \u221231.4%, and \u221235.0% for Courses 1, 2, and 3, respectively. Patients experienced sustained improvements in anemia, pain, and quality of life during treatment. Most adverse events were mild\/moderate in severity and decreased in frequency with each course. Seven serious adverse events (six patients) were reported; anemia, embolic cerebral infarction, and pituitary apoplexy (one patient each) were considered UPA\u2010related. Nonphysiological changes in endometrial histology were transient and benign. No safety concerns were detected in hormone concentrations or liver function tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Long\u2010term administration of 10\u2010mg UPA is effective for reducing symptoms associated with uterine fibroids in Japanese women. UPA was well tolerated and few safety concerns were reported.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jog.14802","type":"journal-article","created":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T00:27:41Z","timestamp":1623284861000},"page":"3269-3278","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Phase <scp>III<\/scp> long\u2010term study to evaluate the efficacy and safety of ulipristal acetate in Japanese patients with uterine fibroids"],"prefix":"10.1111","volume":"47","author":[{"given":"Yutaka","family":"Osuga","sequence":"first","affiliation":[{"name":"Department of Gynecologic Surgery The University of Tokyo Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuaki","family":"Nakano","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Yamauchi","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitoshi","family":"Murakawa","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,6,9]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.13102"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2014-006360"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/00006250-200202000-00021"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2013.830974"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6874-12-6"},{"key":"e_1_2_8_7_1","first-page":"CD000547","article-title":"Preoperative medical therapy before surgery for uterine fibroids","volume":"11","author":"Lethaby A","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003141"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103182"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0303-7207(01)00743-2"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2006-2816"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2015.04.025"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103180"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2014.02.008"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2018.1550070"},{"key":"e_1_2_8_16_1","unstructured":"European Medicines Agency.2020. PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids September 4 2020. [Cited 28 Oct 2020]. Available fromhttps:\/\/www.ema.europa.eu\/en\/news\/prac-recommends-revoking-marketing-authorisation-ulipristal-acetate-uterine-fibroids."},{"key":"e_1_2_8_17_1","unstructured":"European Medicines Agency.2021. Ulipristal acetate 5mg medicinal products January 14 2021. [Cited 28 February 2021]. Available fromhttps:\/\/www.ema.europa.eu\/en\/medicines\/human\/referrals\/ulipristal-acetate-5mg-medicinal-products."},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/rmb2.12304"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2021.01.023"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.1990.tb16249.x"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2016.11.003"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-010-9919-6"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0173523"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/PGP.0b013e318251035b"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2018.00350"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-04-0944"},{"key":"e_1_2_8_27_1","unstructured":"Food and Drug Administration.2020. Guidance for industry. Drug\u2010induced liver injury: Premarketing clinical evaluation. [Cited 7 Aug 2020]. 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