Actively Recruiting
An Open-Label Applicator Tampon Safety-in-Use Study
Led by Kimberly-Clark Corporation · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm the safety of a commercially available tampon in healthy women aged 18 to 49 who have regular menstrual cycles. The study focuses on evaluating the occurrence of any tampon-related adverse events during and shortly after a menstrual cycle, providing important safety information for users. The trial is sponsored by Kimberly-Clark Corporation and involves female volunteers who have experience with applicator tampons. Participants will use the study tampon, available in regular, super, and super plus absorbencies, as they normally would during one menstrual cycle. The study is open-label, meaning all participants know they are using the test tampon. Gynecological exams will be performed before and after the menstrual cycle to monitor safety and any reactions. During the study, participants will track their menstruation and use at least six tampons as usual. Researchers will assess safety by recording any adverse events from enrollment until seven days after the last visit. Participants will undergo gynecological exams and agree to follow study procedures and scheduled appointments. The total study duration covers one menstrual cycle plus the follow-up period for safety monitoring.
CONDITIONS
Brief Title
Tampon Safety-in-Use Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 3 months 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 able to confidently predict onset of menstruation.
- Normally uses at least 6 tampons for protection during menstruation.
- Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection.
- Agrees to all study procedures, including gynecological exams and 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.
You will not qualify if you...
- Pregnant, lactating, or trying to become pregnant.
- Less than six weeks post-partum.
- Has a menstrual abnormality such as oligomenorrhea or amenorrhea.
- Known allergy or sensitivity to components of the investigational products.
- Any other medical condition or history that could compromise study results or participant safety as determined by the Investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to 7 days after the last use of the test tampon
Participants use the test tampon (commercially available applicator tampons in regular, super, and super plus absorbencies) during their menstrual periods as part of the study.
Visits scheduled around menstrual cycles during the study period
Trial Site Locations
Total: 1 location
1
Princeton Consumer Research
St. Petersburg, Florida, United States, 33702
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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