{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T16:52:20Z","timestamp":1793206340315,"version":"4.5.0"},"reference-count":41,"publisher":"The Endocrine Society","issue":"8","license":[{"start":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T00:00:00Z","timestamp":1675382400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Vasomotor symptoms (VMS) are common, bothersome, and can persist for years before and after menopause.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We aimed to assess efficacy\/safety of fezolinetant for treatment of moderate to severe VMS associated with menopause.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this double-blind, placebo-controlled, 12-week phase 3 trial with a 40-week active treatment extension (NCT04003142; SKYLIGHT 2), women aged 40 to 65 years with minimum average 7 moderate to severe VMS\/day were randomized to 12 weeks of once-daily placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Completers were rerandomized to fezolinetant 30\/45 mg for 40 additional weeks. Coprimary efficacy endpoints were mean daily change from baseline to week 4 (W4) and W12 in VMS frequency and severity. Safety was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Both fezolinetant doses statistically significantly reduced VMS frequency\/severity at W4 and W12 vs placebo. For VMS frequency, W4 least squares mean (SE) reduction vs placebo: fezolinetant 30 mg, \u20131.82 (0.46; P &amp;lt; .001); 45 mg, \u20132.55 (0.46; P &amp;lt; .001); W12: 30 mg, \u20131.86 (0.55; P &amp;lt; .001); 45 mg, \u22122.53 (0.55; P &amp;lt; .001). For VMS severity, W4: 30 mg, \u22120.15 (0.06; P &amp;lt; .05); 45 mg, \u22120.29 (0.06; P &amp;lt; .001); W12: 30 mg, \u22120.16 (0.08; P &amp;lt; .05); 45 mg, \u22120.29 (0.08; P &amp;lt; .001). Improvement in VMS frequency and severity was observed by W1 and maintained through W52. Serious treatment-emergent adverse events were infrequent, reported by 2%, 1%, and 0% of those receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Daily fezolinetant 30 and 45 mg were efficacious and well tolerated for treating moderate to severe VMS associated with menopause.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgad058","type":"journal-article","created":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T04:00:30Z","timestamp":1675396830000},"page":"1981-1997","source":"Crossref","is-referenced-by-count":196,"title":["Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT"],"prefix":"10.1210","volume":"108","author":[{"given":"Kimball A","family":"Johnson","sequence":"first","affiliation":[{"name":"iResearch Atlanta, LLC, Decatur , Georgia 30030 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy","family":"Martin","sequence":"additional","affiliation":[{"name":"Employee of Astellas Pharma Global Development at the Time of the Study , Northbrook, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rossella E","family":"Nappi","sequence":"additional","affiliation":[{"name":"Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, and Research Center for Reproductive Medicine and Gynecological Endocrinology \u2013 Menopause Unit, Fondazione Policlinico IRCCS S. 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Wolfman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Toronto , Toronto, Ontario M5G 1E2 , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marci","family":"English","sequence":"additional","affiliation":[{"name":"Global Development, Astellas Pharma Global Development, Inc. , Northbrook, IL 60062 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Franklin","sequence":"additional","affiliation":[{"name":"Employee of Astellas Pharma Global Development at the Time of the Study , Northbrook, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Misun","family":"Lee","sequence":"additional","affiliation":[{"name":"Biostatistics, Astellas Pharma Global Development, Inc. , Northbrook, IL 60062 , 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