Tampon Design Validation Study

Kimberly-Clark

Status: Completed

Conditions: Menstruation

Treatments: Device: Tampon CS; Device: Tampon BR; Device: Tampon CR; Device: Tampon BS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05553600

AFC-21-001

Details and patient eligibility

About

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.

Enrollment: 732 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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732 participants in 2 patient groups

Regular Absorbency

Other group

Description:

Modified regular absorbency tampon versus regular absorbency reference tampon

Treatment:

Device: Tampon CR

Device: Tampon BR

Super Absorbency

Other group

Description:

Modified super absorbency tampon versus super absorbency reference tampon

Treatment:

Device: Tampon CS

Device: Tampon BS