Tampon Design Validation Study
An Open-Label Clinical Validation Study of an Applicator Tampon
1 other identifier
interventional
732
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2023
CompletedResults Posted
Study results publicly available
January 17, 2024
CompletedJanuary 17, 2024
December 1, 2023
7 months
September 16, 2022
November 14, 2023
December 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Validation of Performance User Needs Based on Participant Diary Responses.
At the end of 1 menstrual period (up to 10 days) 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
Validation of Packaging/Labeling User Needs Based on Interview Responses
At baseline, prior to any interventions
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
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
- +2 more secondary outcomes
Study Arms (2)
Regular Absorbency
OTHERModified regular absorbency tampon versus regular absorbency reference tampon
Super Absorbency
OTHERModified super absorbency tampon versus super absorbency reference tampon
Interventions
Eligibility Criteria
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 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.
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, including rayon.
- Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
Velocity Clinical Research
Boise, Idaho, 83642, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
Princeton Consumer Research
Raritan, New Jersey, 08869, United States
Velocity Clinical Research
Anderson, South Carolina, 29621, United States
Velocity Clinical Research
Greenville, South Carolina, 29615, United States
Signature Gyn Services
Fort Worth, Texas, 76104, United States
TMC Life Research, Inc.
Houston, Texas, 77054, United States
Results Point of Contact
- Title
- Jin Zhang
- Organization
- Kimberly-Clark Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 23, 2022
Study Start
October 21, 2022
Primary Completion
May 5, 2023
Study Completion
May 5, 2023
Last Updated
January 17, 2024
Results First Posted
January 17, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share