NCT05553600CompletedNot Applicable
An Open-Label Clinical Validation Study of an Applicator Tampon
Kimberly-Clark Corporation9 sites in 1 country732 target enrollmentStarted: October 21, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kimberly-Clark Corporation
- Enrollment
- 732
- Locations
- 9
- Primary Endpoint
- The Percentage of Used Tampons That Have Elongated
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
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.
Arms & Interventions
Regular Absorbency
Other
Modified regular absorbency tampon versus regular absorbency reference tampon
Intervention: Tampon BR (Device)
Regular Absorbency
Other
Modified regular absorbency tampon versus regular absorbency reference tampon
Intervention: Tampon CR (Device)
Super Absorbency
Other
Modified super absorbency tampon versus super absorbency reference tampon
Intervention: Tampon BS (Device)
Super Absorbency
Other
Modified super absorbency tampon versus super absorbency reference tampon
Intervention: Tampon CS (Device)
Outcomes
Primary Outcomes
The Percentage of Used Tampons That Have Elongated
Time Frame: 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 Outcomes
- Validation of Performance User Needs Based on Participant Diary Responses(At the end of 1 menstrual period (up to 10 days) for each intervention)
- 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)
- Validation of Performance User Needs Based on Participant Diary Responses.(At the end of 1 menstrual period (up to 10 days) for each intervention)
- 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)
- 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: 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)
- Validation of Packaging/Labeling User Needs Based on Interview Responses(At baseline, prior to any interventions)
Investigators
Study Sites (9)
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