Tampon Design Validation Study

Not Applicable

Completed

• Conditions: Menstruation
• Interventions: Device: Tampon BS; Device: Tampon BR; Device: Tampon CR; Device: Tampon CS

• Registration Number: NCT05553600
• Lead Sponsor: Kimberly-Clark Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2022-10-21
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Results First Submitted: 2023-11-14
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Results First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 732

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Regular Absorbency	Tampon CR	Modified regular absorbency tampon versus regular absorbency reference tampon
Super Absorbency	Tampon BS	Modified super absorbency tampon versus super absorbency reference tampon
Regular Absorbency	Tampon BR	Modified regular absorbency tampon versus regular absorbency reference tampon
Super Absorbency	Tampon CS	Modified super absorbency tampon versus super absorbency reference tampon

Primary Outcome Measures

Name	Time	Method
The Percentage of Used Tampons That Have Elongated	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 Outcome Measures

Name	Time	Method
Validation of Performance User Needs Based on Participant Diary Responses	At the end of 1 menstrual period (up to 10 days) for each intervention	Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.
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	Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location
Validation of Performance User Needs Based on Participant Diary Responses.	At the end of 1 menstrual period (up to 10 days) for each intervention	Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.
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	Vaginal pH after tampon use.
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 prior to and following tampon use including: number of participants with suspected infections, other abnormal finding, and exam results that the investigators found clinically significant.
Validation of Packaging/Labeling User Needs Based on Interview Responses	At baseline, prior to any interventions	Proportion of participants able to locate key packaging/labeling information.
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	Vaginal pH prior to tampon use.

Trial Locations

Locations (7)

Del Sol Research Management, LLC; 🇺🇸 Tucson, Arizona, United States

Velocity Clinical Research; 🇺🇸 Greenville, South Carolina, United States

Princeton Consumer Research; 🇺🇸 Raritan, New Jersey, United States

Signature Gyn Services; 🇺🇸 Fort Worth, Texas, United States

Agile Clinical Research Trials, LLC; 🇺🇸 Atlanta, Georgia, United States

Best Clinical Trials, LLC; 🇺🇸 New Orleans, Louisiana, United States

TMC Life Research, Inc.; 🇺🇸 Houston, Texas, United States