An Open-Label Clinical Validation Study of an Applicator Tampon

Kimberly-Clark Corporation7 sites in 1 country732 target enrollmentOctober 21, 2022

ConditionsMenstruation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Menstruation
Sponsor: Kimberly-Clark Corporation
Enrollment: 732
Locations: 7
Primary Endpoint: The Percentage of Used Tampons That Have Elongated
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.

Registry

clinicaltrials.gov

Start Date

October 21, 2022

End Date

May 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Kimberly-Clark Corporation

Responsible Party

Sponsor

Eligibility Criteria

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 without discomfort.
•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 (if applicable), 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.

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, including rayon.
•Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.

Outcomes

Primary Outcomes

The Percentage of Used Tampons That Have Elongated

Time Frame: At the end of 1 menstrual period (up to 10 days) for each intervention

The percentage of used tampons within each test code that have elongated \>10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.

Secondary Outcomes

Validation of Performance User Needs Based on Participant Diary Responses(At the end of 1 menstrual period (up to 10 days) for each intervention)
Number of Subjects That Had Any Lesions Noted During Gynecological Exam(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
Validation of Performance User Needs Based on Participant Diary Responses.(At the end of 1 menstrual period (up to 10 days) for each intervention)
Additional Gynecological Exam Results: Post-use Vaginal pH(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
Additional Gynecological Exam Results: Pre-use Vaginal pH(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
Validation of Packaging/Labeling User Needs Based on Interview Responses(At baseline, prior to any interventions)