{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T22:48:33Z","timestamp":1787006913082,"version":"build-2736575974"},"reference-count":0,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2000,1,1]],"date-time":"2000-01-01T00:00:00Z","timestamp":946684800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Infectious Diseases in Obstetrics and Gynecology"],"published-print":{"date-parts":[[2003,1]]},"abstract":"\n Objective:<\/jats:italic>\n To confirm the safety of a new experimental Tampax\u2009\n \n \u00ae<\/jats:italic>\n <\/jats:sup>\n tampon and applicator compared with that\nof a currently marketed Tampax\u2009\n \n \u00ae<\/jats:italic>\n <\/jats:sup>\n tampon and applicator using comprehensive gynecological and microbiological\nassessments.\n <\/jats:p>\n \n Methods:<\/jats:italic>\n A 2\u2010month, single\u2010blind, randomized, crossover study was conducted in which each subject served\nas her own control. Safety was evaluated by comparing potential product\u2010related irritation (using colposcopic\nexamination and subject diary data), assessment of vaginal discharge, vaginal pH, and effects on selected microorganisms\n(yeast,\n Escherichia coli<\/jats:italic>\n ,\n Staphylococcus aureus<\/jats:italic>\n and group B streptococci) obtained by vaginal swab\ncultures after normal menstrual use in the experimental and control groups.\n <\/jats:p>\n \n Results:<\/jats:italic>\n In total, 110 women completed the study. There were no significant differences between the groups\nthat used either the experimental or control tampon with regard to prevalence or mean cell density for the\nselected microorganisms. No differences were observed in the incidence or severity of erythema, in abrasion\nor ulceration of the cervix, vagina, introitus, vulva or perineum, or in mean vaginal pH and discharge assessments.\nThere were equivalent low incidences of reported symptoms such as discomfort during insertion, wear or removal,\nand a similar low incidence of burning, stinging or itching during use of either the control or experimental tampon.\nThere was a more favorable overall product rating for the experimental tampon (\n p<\/jats:italic>\n = 0.003).\n <\/jats:p>\n \n Conclusions:<\/jats:italic>\n This approach provides a combination of gynecological, microbiological and self\u2010reported (diary\nrecall) methodologies in order to assess tampon safety during use more thoroughly than has previously been\nreported, and it supports a comparable safety profile for the experimental tampon and a currently marketed\ntampon.\n <\/jats:p>","DOI":"10.1080\/10647440300025504","type":"journal-article","created":{"date-parts":[[2005,9,7]],"date-time":"2005-09-07T01:29:38Z","timestamp":1126056578000},"page":"89-99","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Clinical Safety\u2010in\u2010Use Study of a New Tampon Design"],"prefix":"10.1155","volume":"11","author":[{"given":"Stacey E.","family":"Shehin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaelle B.","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne E.","family":"Hochwalt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank C.","family":"Sarbaugh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Nunn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2003,4,22]]},"container-title":["Infectious Diseases in Obstetrics and Gynecology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/downloads.hindawi.com\/journals\/idog\/2003\/489014.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1080\/10647440300025504","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T17:13:31Z","timestamp":1723050811000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1080\/10647440300025504"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,1]]},"references-count":0,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2003,1]]}},"alternative-id":["10.1080\/10647440300025504"],"URL":"https:\/\/doi.org\/10.1080\/10647440300025504","archive":["Portico"],"relation":{},"ISSN":["1064-7449"],"issn-type":[{"value":"1064-7449","type":"print"}],"subject":[],"published":{"date-parts":[[2003,1]]},"assertion":[{"value":"2002-09-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2003-04-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2003-04-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}