Tampon Safety-in-Use Study

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

The goal of this clinical trial is to confirm the safety of a tampon in healthy female volunteers. Participants will use the study tampons as they normally would for one menstrual cycle. Gynecological exams will be conducted before and after the menstrual cycle.

Study Overview

• Status: Recruiting
• Conditions: Menstruation
• Intervention / Treatment: Device: Tampon A

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33702
      • Recruiting
      • Princeton Consumer Research
      • Contact: Christine Maraghy; Phone Number: 727-576-7300; Email: info@princetonconsumer.com
      • Principal Investigator: Christine Maraghy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Tampon	Device: Tampon A; Commercially available tampons in regular, super, and super plus absorbencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Tampon Related Adverse Events	Frequency and severity of tampon related adverse events	From enrollment to 7 days post last visit

Collaborators and Investigators

• Sponsor: Kimberly-Clark Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 8, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CNS-2026-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No