Safety and Tolerability in Healthy Volunteers
Conditions
Brief summary
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
Interventions
DEVICETampon
Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.
Sponsors
Lyv Life Inc. (dba: Cora)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon | 3 months | To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome. | 3 months | Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome. |
Countries
United States
Contacts
CONTACTChrissy Maraghy
Outcome results
None listed