Tampon Design Validation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

732 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-21

Study Completion Date

2023-05-05

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.

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Detailed Description

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Conditions

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Menstruation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Regular Absorbency

Modified regular absorbency tampon versus regular absorbency reference tampon

Group Type OTHER

Tampon BR

Intervention Type DEVICE

Modified Regular Absorbency Tampons

Tampon CR

Intervention Type DEVICE

Reference Regular Absorbency Tampons

Super Absorbency

Modified super absorbency tampon versus super absorbency reference tampon

Group Type OTHER

Tampon BS

Intervention Type DEVICE

Modified Super Absorbency Tampons

Tampon CS

Intervention Type DEVICE

Reference Super Absorbency Tampons

Interventions

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Tampon BR

Modified Regular Absorbency Tampons

Intervention Type DEVICE

Tampon CR

Reference Regular Absorbency Tampons

Intervention Type DEVICE

Tampon BS

Modified Super Absorbency Tampons

Intervention Type DEVICE

Tampon CS

Reference Super Absorbency Tampons

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes