Tampon Design Validation Study

An Open-Label Clinical Validation Study of an Applicator Tampon

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.

Study Overview

• Status: Completed
• Conditions: Menstruation
• Intervention / Treatment: Device: Tampon BR; Device: Tampon CR; Device: Tampon BS; Device: Tampon CS

• Study Type: Interventional
• Enrollment (Actual): 732
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
  • Idaho
    • Boise, Idaho, United States, 83642
      • Velocity Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Best Clinical Trials, LLC
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Princeton Consumer Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Signature Gyn Services
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc.

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Regular Absorbency; Modified regular absorbency tampon versus regular absorbency reference tampon	Device: Tampon BR; Modified Regular Absorbency Tampons; Device: Tampon CR; Reference Regular Absorbency Tampons
Other: Super Absorbency; Modified super absorbency tampon versus super absorbency reference tampon	Device: Tampon BS; Modified Super Absorbency Tampons; Device: Tampon CS; Reference Super Absorbency Tampons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Kimberly-Clark Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AFC-21-001

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