{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T22:59:43Z","timestamp":1791413983774,"version":"4.3.3"},"reference-count":39,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"ASKA Pharmaceutical Co., Ltd"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Reprod Medicine &amp; Biology"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>A multicenter, randomized, double\u2010blind, placebo\u2010controlled trial was conducted to evaluate the efficacy, safety, and appropriate dose of ulipristal acetate (UPA) in Japanese women with symptomatic uterine fibroids (UFs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 121 premenopausal women with UFs were enrolled to receive either placebo, UPA\u20102.5\u00a0mg, UPA\u20105\u00a0mg, UPA\u201010\u00a0mg, or leuprorelin acetate (LEU), a reference drug, for 12\u00a0weeks. The primary end point was the rate of patients having achieved amenorrhea for 35\u00a0days at Week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The rates for amenorrhea were 4.5%, 60.0%, 72.7%, 88.0%, and 76.2% in the placebo, UPA\u20102.5\u00a0mg, UPA\u20105\u00a0mg, UPA\u201010\u00a0mg, and LEU groups, respectively. The median times to amenorrhea were 20.0, 5.0, 5.0, and 23.0\u00a0days for treatment with UPA\u20102.5\u00a0mg, UPA\u20105\u00a0mg, UPA\u201010\u00a0mg, and LEU, respectively. A significant dose\u2010response of UPA for the rate of amenorrhea was observed. The overall incidence rates of adverse events were 45.8% in the placebo group, 56.5%\u201080.0% in the UPA groups, and 100.0% in the LEU group. There were no notable safety issues with UPA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Ulipristal acetate was effective and well tolerated in Japanese women with UFs. 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