{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:14:44Z","timestamp":1787015684257,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,6,15]],"date-time":"2025-06-15T00:00:00Z","timestamp":1749945600000},"content-version":"vor","delay-in-days":14,"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":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of 4\u2009mg of drospirenone (DRSP), a progestin\u2010only pill (POP), for contraception in Japanese women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicenter, open\u2010label, single\u2010arm study. The dosing period of DRSP was 13\u2009cycles, each lasting for 28\u2009days. In one cycle, 4\u2009mg of DRSP was administered orally once daily for the first 24\u2009days, followed by a placebo for 4\u2009days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Data from 276 subjects were analyzed, with a total of 3319 DRSP exposure cycles. Pregnancy occurred in one subject. The overall Pearl Index [95% CI] was 0.39 [0.01, 2.18], and the cumulative pregnancy rate [95% CI] was 0.40% [0.06, 2.81]. Of the 276 subjects, 273 (98.9%) experienced treatment\u2010emergent adverse events (TEAEs) and 264 (95.7%) experienced adverse drug reactions. All TEAEs were mild or moderate, with no severe events. The most common TEAE was intermenstrual bleeding (irregular uterine bleeding) (89.5%). Although 31.9% of the subjects had risk factors for venous thromboembolism (VTE), no VTE\u2010related TEAEs were observed. The incidence of unscheduled bleeding [95% CI] across all cycles was 91.6% [87.7, 94.3].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>DRSP, the first POP in Japan, is effective and safe as a contraceptive in Japanese women. It provides a new contraceptive option for Japanese women, including those at risk of VTE for whom combined oral contraceptives are contraindicated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jog.16340","type":"journal-article","created":{"date-parts":[[2025,6,15]],"date-time":"2025-06-15T20:54:13Z","timestamp":1750020853000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and safety of drospirenone as a progestin\u2010only pill in Japanese women: A phase\n                    <scp>III<\/scp>\n                    study"],"prefix":"10.1111","volume":"51","author":[{"given":"Kunio","family":"Kitamura","sequence":"first","affiliation":[{"name":"Japan Family Planning Association  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Colli","sequence":"additional","affiliation":[{"name":"Research and Development Department Exeltis  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoko","family":"Kikuyama","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rieko","family":"Azuma","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2439-4969","authenticated-orcid":false,"given":"Tomoya","family":"Kagawa","sequence":"additional","affiliation":[{"name":"Clinical Development Department ASKA Pharmaceutical Co., Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.4091\/iken.2019.003"},{"key":"e_1_2_10_3_1","unstructured":"Ministry of Health Labor and Welfare.Overview of Health Administration Reports 2022.2022. Available fromhttps:\/\/www.mhlw.go.jp\/toukei\/saikin\/hw\/eisei_houkoku\/22\/dl\/kekka5.pdf"},{"key":"e_1_2_10_4_1","first-page":"1","article-title":"SRHR is gradually becoming more widespread","volume":"159","author":"Kitamura K","year":"2024","journal-title":"Monthly J Sex Educ Today"},{"key":"e_1_2_10_5_1","unstructured":"United Nations.Contraceptive Use by Method 2019 Data book.2019. Available fromhttps:\/\/digitallibrary.un.org\/record\/3849735?v=pdf"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(87)80129-1"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2021.769187"},{"key":"e_1_2_10_8_1","unstructured":"Japan Society of Obstetrics and Gynecology.OC LEP Guideline (Guidelines for low\u2010dose oral contraceptives and low\u2010dose estrogen\u2010progestin combination drugs).2020CQ702. p105. (in Japanese)."},{"key":"e_1_2_10_9_1","unstructured":"Organization WH.Progestin\u2010Only Pills. Family Planning: A Global Handbook for Providers. Available from2022https:\/\/www.who.int\/publications\/i\/item\/9780999203705"},{"key":"e_1_2_10_10_1","unstructured":"Organon Pharma (UK) Limited.Cerazette 75 microgram film\u2010coated tablet. Summary of Product Characteristics.2022."},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.steroids.2003.08.008"},{"key":"e_1_2_10_12_1","unstructured":"Drugs@FDA.SLYND package insert.2019. Available fromhttps:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/"},{"key":"e_1_2_10_13_1","unstructured":"Exeltis UK Ltd.Slynd 4mg film\u2010coated tablets. Summary of product characteristics. Updated 15\u2010Nov\u20102023."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3109\/13625187.2015.1044082"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/13625187.2024.2375285"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2015.07.014"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.conx.2020.100020"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-019-05340-4"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-020-01080-9"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2015.12.007"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/jog.15881"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.13688"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200210008"},{"key":"e_1_2_10_24_1","first-page":"89","article-title":"Guidelines for clinical evaluation of oral contraceptives","volume":"29","author":"Yamada M","year":"1987","journal-title":"The Pharma Monthly"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2009.01.016"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03256908"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare11091304"},{"key":"e_1_2_10_28_1","unstructured":"The American College of Obstetricians and Gynecolotgists.FAQs for patients. Progestin\u2010only hormonal birth control: pill and injection. Available fromhttps:\/\/www.acog.org\/womens\u2010health\/faqs\/Progestin\u2010Only\u2010Hormonal\u2010Birth\u2010Control\u2010Pill\u2010and\u2010Injection?utm_source=redirect&utm_medium=web&utm_campaign=otn#take"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2023.109978"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1111840"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2016.09.027"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-7824(02)00537-1"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10456-005-9003-z"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1783\/147118902101196784"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xagr.2023.100266"},{"issue":"15","key":"e_1_2_10_36_1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0231856","article-title":"Bleeding profile of women using a drospirenone\u2010only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg","volume":"29","author":"Palacios S","year":"2020","journal-title":"PLoS One"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1080\/13625187.2023.2276668"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-022-06853-1"}],"container-title":["Journal of Obstetrics and Gynaecology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jog.16340","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T20:31:40Z","timestamp":1760646700000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/jog.16340"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":37,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1111\/jog.16340"],"URL":"https:\/\/doi.org\/10.1111\/jog.16340","archive":["Portico"],"relation":{},"ISSN":["1341-8076","1447-0756"],"issn-type":[{"value":"1341-8076","type":"print"},{"value":"1447-0756","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2024-11-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e16340"}}