Clinical Trials in the USA / NCT07807891
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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