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โ† Trials
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Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon

RecruitingNAAges 18 Years - 49 YearsFemaleLyv Life Inc. (dba: Cora)
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female, 18-49, good general health, written informed consent Regular cycles \~21-35 days with โ‰ฅ4 days menstruation; can predict onset within 72 hrs History of ultra/super-plus tampon use; normally uses โ‰ฅ4 ultra (15-18 g) or super-plus (12-15 g) tampons/cycle Willing to use only provided products (tampons + liners + pads) and complete diary/returns Access to a freezer to store used tampons Normal Pap within 3 yrs (or normal Pap + negative HPV within 5 yrs) Acceptable birth control โ‰ฅ1 month prior and through study Willing to undergo 4 gyn exams (speculum + colposcope) over 2 cycles Exclusion Criteria: * Uncontrolled chronic disease (e.g., IDDM, HIV/AIDS); active genital herpes in last 3 yrs Menstrual abnormality (oligomenorrhea/amenorrhea) Abnormal Pap in last 3 yrs / positive HPV in last 5 yrs / gyn cancer or disorder History of TSS in last year or PID in past year Allergy/sensitivity to tampon components or exam lubricant Pregnant, planning pregnancy, nursing/lactating, or \<6 weeks post-partum Active vaginal infection, UTI, yeast infection, or hemorrhoids at exam Type B/C lesions, or Type A lesions covering \>50% of a site, at baseline
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What it tests

  • Tampon
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Where

1 site
Princeton Consumer Research (PCR)
St. Petersburg, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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