Tampon safety during regular use

An Open-Label Applicator Tampon Safety-in-Use Study

This study tests whether a new tampon is safe for healthy women ages 18–49 when used normally for one menstrual cycle.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: Kimberly-Clark Corporation (Industry-sponsored)
• Locations: 1 site (St. Petersburg, Florida)
• Trial ID: NCT07561905 on ClinicalTrials.gov

What this trial studies

Healthy women who regularly use applicator tampons are asked to use the study tampon for one menstrual cycle while keeping their usual tampon routine. Gynecological exams are performed before and after the cycle to check for irritation, infection, or other adverse effects. Participants must have regular menstrual cycles, a recent history of tampon use, and use an acceptable form of birth control during the study. The trial is conducted at a single consumer research site in St. Petersburg, Florida, and requires scheduled in-person visits.

Who should consider this trial

Good fit: Healthy females aged 18–49 with regular 21–35 day menstrual cycles who routinely use applicator tampons (typically at least six per period) and who use an acceptable form of birth control are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, outside the 18–49 age range, have irregular cycles, do not normally use tampons, or have active gynecologic conditions are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, it could confirm the tampon is safe for normal use and give users greater confidence in the product.

How similar studies have performed: Similar manufacturer-led tampon safety-in-use studies are common and have generally not identified major safety concerns when products are used as directed.

Eligibility criteria

Key Inclusion Criteria:

* Willing and able to read and provide written informed consent.
* Female in good general health, age 18-49 (inclusive).
* History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period.
* History of use of applicator tampons within the past 12 months without discomfort.
* Tracks menstruation and be able to confidently predict onset of menstruation
* Normally use at least 6 tampons for protection during menstruation.
* Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection.
* Agrees to the conduct of all study procedures, including gynecological exams and agrees to follow all study instructions and return for scheduled appointments.
* Has used an acceptable form of birth control for at least one month prior to enrollment and for the duration of the study.

Key Exclusion Criteria:

* Pregnant, lactating or is trying to become pregnant.
* Less than six (6) weeks post-partum.
* Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
* Has a known allergy or sensitivity to components of the investigational products
* Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.

Where this trial is running

St. Petersburg, Florida

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

Conditions Menstruation