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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
120
Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.
Princeton Consumer Research (PCR)
St. Petersburg, Florida, United States
RECRUITINGTo evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon
Time frame: 3 months
Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.
Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.
Time frame: 3 months
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