Tampon Design Validation Study

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Clinical Validation Study of an Applicator Tampon

Conditions
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Menstruation

Intervention / Treatment
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* Device: Tampon BR
* Device: Tampon CR
* Device: Tampon BS
* Device: Tampon CS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regular Absorbency<br>Modified regular absorbency tampon versus regular absorbency reference tampon | Device: Tampon BR<br>* Modified Regular Absorbency Tampons<br>Device: Tampon CR<br>* Reference Regular Absorbency Tampons<br>|
| Other: Super Absorbency<br>Modified super absorbency tampon versus super absorbency reference tampon | Device: Tampon BS<br>* Modified Super Absorbency Tampons<br>Device: Tampon CS<br>* Reference Super Absorbency Tampons<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampon integrity | The proportion of used tampons that have elongated | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Needs | User needs of performance and safety | 1 month |