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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
732
Del Sol Research Management, LLC
Tucson, Arizona, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Velocity Clinical Research
Boise, Idaho, United States
Best Clinical Trials, LLC
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.
Time frame: 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 participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Reference Super Absorbency Tampons
New Orleans, Louisiana, United States
Princeton Consumer Research
Raritan, New Jersey, United States
Velocity Clinical Research
Anderson, South Carolina, United States
Velocity Clinical Research
Greenville, South Carolina, United States
Signature Gyn Services
Fort Worth, Texas, United States
TMC Life Research, Inc.
Houston, Texas, United States
Time frame: 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.
Time frame: 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.
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention