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(dba: Cora)","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":15},[9],{"measure":10,"description":10,"timeFrame":11},"To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon","3 months",[13],{"measure":14,"description":14,"timeFrame":11},"Adverse events - incidence, type, frequency, severity (mild\u002Fmoderate\u002Fsevere), seriousness (AE vs. SAE), device-relatedness, and outcome.",null,{"allocation":17,"interventionModel":18,"interventionModelDescription":15,"primaryPurpose":19,"observationalModel":15,"timePerspective":15,"maskingInfo":20},"RANDOMIZED","CROSSOVER","OTHER",{"masking":21,"maskingDescription":15,"whoMasked":22},"QUADRUPLE",[23,24,25,26],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[28,33],{"label":29,"type":30,"description":15,"interventionNames":31},"Unibeauty organic cotton ultra absorbency tampon","EXPERIMENTAL",[32],"Device: Tampon",{"label":34,"type":35,"description":15,"interventionNames":36},"Tampax Pearl","ACTIVE_COMPARATOR",[32],[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":15},"DEVICE","Tampon","Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.",[34,29],[44],{"name":45,"role":46,"phone":47,"phoneExt":15,"email":48},"Chrissy Maraghy","CONTACT","(727) 576 7300","chrissy@princetonconsumer.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Princeton Consumer Research (PCR)","RECRUITING","St. Petersburg","Florida","33702","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-82.67927,27.77086,{"lat":62,"lon":61},[65,66],{"name":45,"role":46,"phone":47,"phoneExt":15,"email":48},{"name":45,"role":67,"phone":15,"phoneExt":15,"email":15},"PRINCIPAL_INVESTIGATOR",{"type":69,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100655069","safety-and-tolerability-of-an-ultra-absorbency-menstrual-tampon-compared-to-a-commercially-marketed-tampon-100655069",false,"NCT07807891","Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon","A Randomized, Open-label, Evaluator-Blinded, Cross-over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon","Inclusion Criteria:\n\n* Female, 18-49, good general health, written informed consent Regular cycles \\~21-35 days with ≥4 days menstruation; can predict onset within 72 hrs History of ultra\u002Fsuper-plus tampon use; normally uses ≥4 ultra (15-18 g) or super-plus (12-15 g) tampons\u002Fcycle Willing to use only provided products (tampons + liners + pads) and complete diary\u002Freturns Access to a freezer to store used tampons Normal Pap within 3 yrs (or normal Pap + negative HPV within 5 yrs) Acceptable birth control ≥1 month prior and through study Willing to undergo 4 gyn exams (speculum + colposcope) over 2 cycles\n\nExclusion Criteria:\n\n* Uncontrolled chronic disease (e.g., IDDM, HIV\u002FAIDS); active genital herpes in last 3 yrs Menstrual abnormality (oligomenorrhea\u002Famenorrhea) Abnormal Pap in last 3 yrs \u002F positive HPV in last 5 yrs \u002F gyn cancer or disorder History of TSS in last year or PID in past year Allergy\u002Fsensitivity to tampon components or exam lubricant Pregnant, planning pregnancy, nursing\u002Flactating, or \\\u003C6 weeks post-partum Active vaginal infection, UTI, yeast infection, or hemorrhoids at exam Type B\u002FC lesions, or Type A lesions covering \\>50% of a site, at baseline",true,"FEMALE","18 Years","49 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"NA","A Randomized, Open-Label, Evaluator-Blinded, Cross-Over Clinical Study to Confirm the Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon",[89],"Safety and Tolerability in Healthy Volunteers","2026-09-01",{"date":92,"type":93},"2026-09-08","ACTUAL",{"date":95,"type":83},"2026-09-10",{"date":97,"type":83},"2027-04-30",{"name":5,"class":6},1]