{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T01:34:11Z","timestamp":1777944851383,"version":"3.51.4"},"reference-count":31,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Womens Health (Lond Engl)"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Vilaprisan is a selective progesterone receptor modulator with demonstrated efficacy in the management of uterine fibroids (UFs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To evaluate the safety and efficacy of vilaprisan in Japanese women with UFs and heavy menstrual bleeding (HMB).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Open-label, parallel-group, Phase 3 randomized clinical trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Japanese women with UFs and HMB were randomly assigned 1:1 to receive vilaprisan (2\u2009mg\/day) for either four treatment periods (TPs) of 12\u2009weeks each separated by one bleeding period (Arm A1) or two TPs of 24\u2009weeks each separated by two bleeding periods (Arm A2). The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of 179 women enrolled, 151 were included in the full analysis set and 148 in the safety analysis set. TEAEs occurred in 79.1% of women, with the majority being mild; events were evenly distributed across both treatment arms. Study drug-related TEAEs were observed in 44.6% of women, and serious TEAEs were reported in 3.4% of women. During the treatment phase, the mean (standard deviation) number of bleeding days per 28\u2009days decreased to 1.40 (1.34)\u2009days in Arm A1 and 1.42 (0.82)\u2009days in Arm A2 from respective baseline values of 5.1 (2.3) and 5.2 (2.0)\u2009days. Median time to onset of amenorrhea was 4\u2009days in TP1 in both arms, and 4\u2009days in TP2 in Arm A1. Absence of bleeding for the last 28\u2009days was more common in TP1 (Arm A1: 91.89%, Arm A2: 89.19%) than TP2 (Arm A1: 80.85%, Arm A2: 85.71%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In this study, vilaprisan 2\u2009mg\/day was found to be well tolerated and efficacious in Japanese women with UFs and HMB. However, the study sponsor later terminated the overall clinical development of vilaprisan due to potential safety concerns from long-term rodent studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration:<\/jats:title>\n                    <jats:p>\n                      The ASTEROID 8 study was registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">https:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n                      (registration number: NCT03476928).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17455057251378954","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T09:31:32Z","timestamp":1759915892000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial"],"prefix":"10.1177","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7325-4173","authenticated-orcid":false,"given":"Mikio","family":"Momoeda","sequence":"first","affiliation":[{"name":"Imperial Gift Foundation, Aiiku Maternal and Child Health Center, Aiiku Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Faustmann","sequence":"additional","affiliation":[{"name":"Bayer AG, Berlin, Germany"},{"name":"Gedeon Richter Plc., Budapest, Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"Groettrup-Wolfers","sequence":"additional","affiliation":[{"name":"Bayer AG, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masami","family":"Kondo","sequence":"additional","affiliation":[{"name":"Bayer Yakuhin Ltd., Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanobu","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Bayer Yakuhin Ltd., Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2315-9148","authenticated-orcid":false,"given":"Christian","family":"Seitz","sequence":"additional","affiliation":[{"name":"Bayer AG, Berlin, Germany"},{"name":"Institute of Clinical Pharmacology and Toxicology, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,10,8]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.14640"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics11081455"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0000000000001438"},{"key":"e_1_3_3_5_2","unstructured":"American College of Obstetricians and Gynecologists. 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Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial. F S Sci 2023; 4: 317\u2013326.","journal-title":"F S Sci"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15014"},{"key":"e_1_3_3_18_2","first-page":"1776","article-title":"CONSORT 2025 statement: updated guideline for reporting randomised trials","volume":"31","author":"Hopewell S","year":"2025","unstructured":"Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet 2025; 31: 1776\u20131783.","journal-title":"Lancet"},{"key":"e_1_3_3_19_2","unstructured":"Food and Drug Administration. Guidance for industry drug-induced liver injury: premarketing clinical evaluation https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/drug-induced-liver-injury-premarketing-clinical-evaluation (2009 accessed 18 October 2023)."},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-020-01555-z"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1211"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002933"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002942"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1904351"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003869"},{"key":"e_1_3_3_26_2","unstructured":"European Medicines Agency. 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