Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorLyv Life Inc. (dba: Cora)
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/super-plus tampon use; normally uses ≥4 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 ≥1 month prior and through study Willing to undergo 4 gyn exams (speculum + colposcope) over 2 cycles
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Tampon
DeviceCommercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Unibeauty organic cotton ultra absorbency tamponExperimental treatment 1 intervention
Group B: Tampax PearlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To 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 monthsSecondary outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov