{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:23:41Z","timestamp":1787167421269,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T00:00:00Z","timestamp":1705968000000},"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":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Drospirenone (DRSP) is a synthetic progestogen approved as a progestin\u2010only pill for contraception in both the United States and Europe. Herein, we conducted a phase I\/II study to evaluate the pharmacokinetics, pharmacodynamics, and safety of DRSP in Japanese women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Single and multiple doses of 4\u2009mg of DRSP were orally administered to healthy premenopausal Japanese women. In the multiple\u2010dose period, 4\u2009mg of DRSP was administered once daily for 24\u2009days. Pharmacokinetics, hormone levels, and adverse events (AEs) were investigated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twelve Japanese women participated in this study. The single\u2010 and multiple\u2010dose pharmacokinetics of DRSP was similar to that reported in previous studies in Caucasians. In the multiple\u2010dose period, no subject displayed a progesterone level of more than 5.03\u2009ng\/mL. AEs were observed in 11 (91.7%) subjects. The most common AE was genital hemorrhage, which was observed in six (50.0%) subjects, followed by diarrhea and acne in four (33.3%) subjects each. All AEs resolved or improved at the end of the study, and complete recovery was confirmed in all subjects at follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The pharmacokinetics of DRSP in Japanese women was similar to that of previous studies performed in Caucasian women. Repeated administration of DRSP maintained low plasma progesterone levels indicating effective inhibition of ovulation. No notable safety concerns were observed. In this phase I\/II study, DRSP had no obvious pharmacokinetic, pharmacodynamic, or safety issues to consider in Japanese women.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jog.15881","type":"journal-article","created":{"date-parts":[[2024,1,23]],"date-time":"2024-01-23T18:39:01Z","timestamp":1706035141000},"page":"682-690","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A phase I\/II study evaluating the pharmacokinetics, pharmacodynamics, and safety of drospirenone as an oral contraceptive in Japanese women"],"prefix":"10.1111","volume":"50","author":[{"given":"Kunio","family":"Kitamura","sequence":"first","affiliation":[{"name":"Japan Family Planning Association  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9137-0950","authenticated-orcid":false,"given":"Enrico","family":"Colli","sequence":"additional","affiliation":[{"name":"Research and Development Department Exeltis  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2406-1985","authenticated-orcid":false,"given":"Rieko","family":"Azuma","sequence":"additional","affiliation":[{"name":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-8043-236X","authenticated-orcid":false,"given":"Ryoko","family":"Kikuyama","sequence":"additional","affiliation":[{"name":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7924-2780","authenticated-orcid":false,"given":"Masayuki","family":"Kanai","sequence":"additional","affiliation":[{"name":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1,23]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"United Nations.Contraceptive use by method 2019. [cited 24 Aug 2023] Available from:https:\/\/digitallibrary.un.org\/record\/3849735"},{"key":"e_1_2_9_3_1","unstructured":"Ministry of Health Labour and Welfare.Overview of Health Administration Reports 2021. [cited 24 Aug 2023] Available from:https:\/\/www.mhlw.go.jp\/toukei\/saikin\/hw\/eisei_houkoku\/21\/"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(77)90888-1"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1976.03270200017021"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(87)80129-1"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2021.769187"},{"key":"e_1_2_9_8_1","unstructured":"Japan Society of Obstetrics and Gynecology.Guidelines for the use of low\u2010dose oral contraceptives (Revised) (in Japanese). [cited 24 Aug 2023] Available from:http:\/\/www.jsognh.jp\/common\/files\/society\/guide_line.pdf"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1111840"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/13625187.2020.1743828"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1783\/147118902101196784"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/14.4.982"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.steroids.2003.08.008"},{"key":"e_1_2_9_14_1","unstructured":"SLYND package insert.Drugs@FDA. 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[Cited 24 Aug 2023] Available from:https:\/\/docetp.mpa.se\/LMF\/Drospirenone%20Exeltis%20Film-coated%20tablet%20ENG%20PAR_09001bee80a2a50e.pdf"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2011.11.001"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2004.07.016"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1783\/147118908786000451"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(01)01824-6"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2019.10.005"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/13625180008500376"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1507\/endocrj1954.27.285"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.21-06-02085.2001"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.3109\/13625187.2015.1044082"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.13688"}],"container-title":["Journal of Obstetrics and Gynaecology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jog.15881","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T00:54:07Z","timestamp":1712105647000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/jog.15881"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,23]]},"references-count":28,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10.1111\/jog.15881"],"URL":"https:\/\/doi.org\/10.1111\/jog.15881","archive":["Portico"],"relation":{},"ISSN":["1341-8076","1447-0756"],"issn-type":[{"value":"1341-8076","type":"print"},{"value":"1447-0756","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,23]]},"assertion":[{"value":"2023-09-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-28","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}