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Completed

NCT Number: NCT05553600

Tampon Design Validation Study

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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Key information

Conditions

Menstruation

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Del Sol Research Management, LLC, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tampon BR

Device

Modified Regular Absorbency Tampons

Tampon CR

Device

Reference Regular Absorbency Tampons

Tampon BS

Device

Modified Super Absorbency Tampons

Tampon CS

Device

Reference Super Absorbency Tampons

Primary outcomes

  1. 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

  1. Validation of Performance User Needs Based on Participant Diary Responses.

    Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention

    Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.

  2. Validation of Performance User Needs Based on Participant Diary Responses

    Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention

    Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.

  3. Validation of Packaging/Labeling User Needs Based on Interview Responses

    Time frame: At baseline, prior to any interventions

    Proportion of participants able to locate key packaging/labeling information.

  4. Number of Subjects That Had Any Lesions Noted During Gynecological Exam

    Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

    Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location

  5. Additional Gynecological Exam Results: Pre-use Vaginal pH

    Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

    Vaginal pH prior to tampon use.

  6. Additional Gynecological Exam Results: Post-use Vaginal pH

    Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

    Vaginal pH after tampon use.

  7. Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results

    Time frame: 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 prior to and following tampon use including: number of participants with suspected infections, other abnormal finding, and exam results that the investigators found clinically significant.

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

An Open-Label Clinical Validation Study of an Applicator Tampon

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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