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Recruiting Not applicable

Safety and Tolerability of an Ultra Absorbency Menstrual Tampon Compared to a Commercially Marketed Tampon

NCT07807891 · tracked via the Priya Life Science USA tracker
Sponsor
Lyv Life Inc. (dba: Cora)
Phase
Not applicable
Started
2026-09-10
Last updated
2026-09-08

Condition(s) studied

Safety and Tolerability in Healthy Volunteers

Investigational drug(s) / intervention(s)

Tampon

Tampon: Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
49 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Princeton Consumer Research (PCR) St. Petersburg Florida Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07807891 on ClinicalTrials.gov ↗ ← All trials in the USA