Ultra Absorbency Tampon Safety in Healthy Volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is randomized and open-label with evaluator blinding and uses a cross-over design to compare a new ultra-absorbency tampon to a marketed tampon. Healthy female volunteers, ages 18-49, will use each product over two menstrual cycles while safety, tolerability, and user experience are monitored. Participants will complete diaries, provide used products for assessment, and undergo four gynecologic examinations. The study aims to confirm that the new tampon is safe for regular use under supervised conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Princeton Consumer Research (PCR)
  St. Petersburg, Florida, United States Recruiting

Study contacts

• Study coordinator: Chrissy Maraghy
• Email: chrissy@princetonconsumer.com
• Phone: (727) 576 7300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.