Recruiting

Ultra Absorbency Tampon

Sponsor:

Lyv Life Inc. (dba: Cora)

Code:

NCT07807891

Conditions

Safety and Tolerability in Healthy Volunteers

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Tampon

Study Details

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

Study ID

NCT07807891

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Unibeauty organic cotton ultra absorbency tampon

active comparator: Tampax Pearl

Interventions

Tampon

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

Primary outcome measure

  • To evaluate the safety of the Unibeauty ultra absorbency tampon relative to a commercially marketed ultra absorbency comparator tampon [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Chrissy Maraghy

(727) 576 7300chrissy@princetonconsumer.com

Locations

Princeton Consumer Research (PCR)

Recruiting

St. Petersburg, Florida, United States, 33702

Contacts

Chrissy Maraghy

(727) 576 7300chrissy@princetonconsumer.com

Principal Investigator:

Chrissy Maraghy

More Information

Sponsor

Lyv Life Inc. (dba: Cora)

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lyv Life Inc. (dba: Cora) on 2026-09-08.