Tampon Safety-in-Use Study

NCT07561905 | Recruiting FDA Device

• 1 other identifier: CNS-2026-0003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menstruation

Outcome Measures

Primary Outcomes (1)

• Incidence of Tampon Related Adverse Events

  Frequency and severity of tampon related adverse events

  From enrollment to 7 days post last visit

Study Arms (1)

Test Tampon

EXPERIMENTAL

Device: Tampon A

Interventions

Tampon A DEVICE

Commercially available tampons in regular, super, and super plus absorbencies

Test Tampon

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kimberly-Clark Corporation: lead

Study Sites (1)

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 8, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)