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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Unibeauty organic cotton ultra absorbency tampon
  • Device: Tampon
    Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.
Active Comparator
Tampax Pearl
  • Device: Tampon
    Commercially marketed comparator tampon used during the assigned menstrual cycle according to the protocol.

Recruiting Locations

Princeton Consumer Research (PCR)
St. Petersburg, Florida 33702
Contact:
Chrissy Maraghy
(727) 576 7300
chrissy@princetonconsumer.com

More Details

Status
Recruiting
Sponsor
Lyv Life Inc. (dba: Cora)

Study Contact

Chrissy Maraghy
(727) 576 7300
chrissy@princetonconsumer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.