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

NCT07807891 | Recruiting FDA Device

• 1 other identifier: CORCLI2F
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Safety and Tolerability in Healthy Volunteers

Outcome Measures

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

  3 months

Secondary Outcomes (1)

• Adverse events - incidence, type, frequency, severity (mild/moderate/severe), seriousness (AE vs. SAE), device-relatedness, and outcome.

  3 months

Study Arms (2)

Unibeauty organic cotton ultra absorbency tampon

EXPERIMENTAL

Device: Tampon

Tampax Pearl

ACTIVE COMPARATOR

Device: Tampon

Interventions

Tampon DEVICE

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

Tampax Pearl; Unibeauty organic cotton ultra absorbency tampon

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lyv Life Inc. (dba: Cora): lead

Study Sites (1)

Princeton Consumer Research (PCR)

St. Petersburg, Florida, 33702, United States

RECRUITING

Central Study Contacts

Chrissy Maraghy

CONTACT

(727) 576 7300; chrissy@princetonconsumer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)