{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T17:48:00Z","timestamp":1774979280788,"version":"3.50.1"},"reference-count":13,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Daewon Pharmaceutical Co., Ltd.\n              https:\/\/ror.org\/05j0gfp71"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Primary dysmenorrhea is a common gynecologic condition that frequently requires pharmacologic treatment. Pelubiprofen, a 2-arylpropionic acid-derived prodrug with relatively selective cyclooxygenase-2 inhibitory activity, has demonstrated analgesic efficacy in acute pain conditions. Methods: This multicenter, randomized, double-blind, placebo-controlled, crossover phase 3 trial randomized 120 women aged 19\u201344 years with primary dysmenorrhea to one of two treatment sequences over two menstrual cycles. Pelubiprofen at 45 mg or a matching placebo was administered at the onset of moderate or severe menstrual pain. The co-primary endpoints were time-weighted sums of the total pain relief (TOTPAR-8) and pain intensity difference (SPID-8) during the first 8 h after dosing. Results: Of 120 randomized women, 115 comprised the modified intention-to-treat population and 116 comprised the safety population. Pelubiprofen demonstrated significantly greater analgesic efficacy than placebo, with least-squares mean TOTPAR-8 values of 22.17 versus 15.50 and SPID-8 values of 10.00 versus 6.17 (both p &lt; 0.0001). Significant between-treatment differences were also observed at 12 h (TOTPAR-12 and SPID-12). Treatment-emergent adverse events occurred in 9\/113 (8.0%) pelubiprofen treatment periods and 10\/112 (8.9%) placebo treatment periods; all events were mild to moderate, and the only serious adverse event occurred during a placebo treatment period and was judged to be unrelated to study treatment. Conclusions: Pelubiprofen at 45 mg provided superior short-term analgesic efficacy compared with placebo and was generally well tolerated in women with primary dysmenorrhea.<\/jats:p>","DOI":"10.3390\/jcm15072658","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T16:34:08Z","timestamp":1774974848000},"page":"2658","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Pelubiprofen for Primary Dysmenorrhea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Trial"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6388-5975","authenticated-orcid":false,"given":"Joo Hyun","family":"Park","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin 16995, Republic of Korea"},{"name":"Institute of Women\u2019s Life Medical Science, Yonsei University College of Medicine, Seoul 03722, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inha","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7852-490X","authenticated-orcid":false,"given":"Sung Pil","family":"Choo","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Inha University Hospital, College of Medicine, Inha University, Incheon 22332, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4223-1395","authenticated-orcid":false,"given":"Jae-Hoon","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seung Hwa","family":"Hong","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Chungbuk National University Hospital, Cheongju 28644, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6338-1512","authenticated-orcid":false,"given":"Jong Kil","family":"Joo","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan 49241, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8700-7990","authenticated-orcid":false,"given":"Hyun Tae","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul 02841, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mi Ran","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon 16499, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong-Yun","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyong Wook","family":"Yi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul 02841, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1754-2212","authenticated-orcid":false,"given":"Sang Ho","family":"Yoon","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Dongguk University Medical College, Goyang 10326, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jung-Ho","family":"Shin","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Korea University College of Medicine, Seoul 02841, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3743-2934","authenticated-orcid":false,"given":"Jung Ryeol","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sung Hoon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2718-6645","authenticated-orcid":false,"given":"SiHyun","family":"Cho","sequence":"additional","affiliation":[{"name":"Institute of Women\u2019s Life Medical Science, Yonsei University College of Medicine, Seoul 03722, Republic of Korea"},{"name":"Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1157-4822","authenticated-orcid":false,"given":"Young Sik","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,31]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1097\/AOG.0000000000004096","article-title":"Primary Dysmenorrhea: Diagnosis and Therapy","volume":"136","author":"Corey","year":"2020","journal-title":"Obstet. Gynecol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"101","DOI":"10.4082\/kjfm.21.0103","article-title":"Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates","volume":"43","author":"Itani","year":"2022","journal-title":"Korean J. Fam. Med."},{"key":"ref_3","unstructured":"Nagy, H., Carlson, K., and Khan, M.A.B. (2025). Dysmenorrhea, StatPearls Publishing."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1678","DOI":"10.1016\/j.jval.2022.03.023","article-title":"Prevalence and Risk Factors of Primary Dysmenorrhea in Students: A Meta-Analysis","volume":"25","author":"Wang","year":"2022","journal-title":"Value Health"},{"key":"ref_5","first-page":"CD001751","article-title":"Nonsteroidal anti-inflammatory drugs for dysmenorrhoea","volume":"2015","author":"Marjoribanks","year":"2015","journal-title":"Cochrane Database Syst. 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