Tampon Design Validation Study

Menstruation Clinical Trial

Official title:

An Open-Label Clinical Validation Study of an Applicator Tampon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553600
• Other study ID #: AFC-21-001
• Status: Completed
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: December 2023
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Menstruation

Intervention

Device:
• Tampon BR
Modified Regular Absorbency Tampons
• Tampon CR
Reference Regular Absorbency Tampons
• Tampon BS
Modified Super Absorbency Tampons
• Tampon CS
Reference Super Absorbency Tampons

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Anderson	South Carolina
United States	Agile Clinical Research Trials, LLC	Atlanta	Georgia
United States	Velocity Clinical Research	Boise	Idaho
United States	Signature Gyn Services	Fort Worth	Texas
United States	Velocity Clinical Research	Greenville	South Carolina
United States	TMC Life Research, Inc.	Houston	Texas
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	Princeton Consumer Research	Raritan	New Jersey
United States	Del Sol Research Management, LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Used Tampons That Have Elongated	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.	At the end of 1 menstrual period (up to 10 days) for each intervention
Secondary	Validation of Performance User Needs Based on Participant Diary Responses.	Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.	At the end of 1 menstrual period (up to 10 days) for each intervention
Secondary	Validation of Performance User Needs Based on Participant Diary Responses	Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.	At the end of 1 menstrual period (up to 10 days) for each intervention
Secondary	Validation of Packaging/Labeling User Needs Based on Interview Responses	Proportion of participants able to locate key packaging/labeling information.	At baseline, prior to any interventions
Secondary	Number of Subjects That Had Any Lesions Noted During Gynecological Exam	Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location	Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Secondary	Additional Gynecological Exam Results: Pre-use Vaginal pH	Vaginal pH prior to tampon use.	Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Secondary	Additional Gynecological Exam Results: Post-use Vaginal pH	Vaginal pH after tampon use.	Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Secondary	Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results	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.	Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention