N/A
N=732
Tampon Design Validation Study
Menstruation
Bottom Line
View on ClinicalTrials.gov: NCT05553600 ↗Enrolled (actual)
732
Serious AEs
0.1%
Results posted
Jan 2024
Primary outcome: Primary: The Percentage of Used Tampons That Have Elongated — 2; 75; 4; 48 tampons
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tampon BR (Device); Tampon CR (Device); Tampon BS (Device); Tampon CS (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kimberly-Clark Corporation
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Used Tampons That Have Elongated |
2; 75; 4; 48 | — |
| SECONDARY Validation of Performance User Needs Based on Participant Diary Responses. |
322; 320; 260; 266; 321; 319 | — |
| SECONDARY Validation of Performance User Needs Based on Participant Diary Responses |
38; 33; 43; 20; 3227; 3133 | — |
| SECONDARY Validation of Packaging/Labeling User Needs Based on Interview Responses |
146; 146; 146; 139; 147; 147 | — |
| SECONDARY Number of Subjects That Had Any Lesions Noted During Gynecological Exam |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Additional Gynecological Exam Results: Pre-use Vaginal pH |
4.81; 4.72; 4.99; 5.14 | — |
| SECONDARY Additional Gynecological Exam Results: Post-use Vaginal pH |
4.85; 4.76; 5.19; 4.86 | — |
| SECONDARY Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results |
0; 0; 1; 0; 6; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05553600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.