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Tampon Design Validation Study

NCT05553600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2024-01-17

Study results available
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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.

Conditions

  • Menstruation

Interventions

DEVICE

Tampon BR

Modified Regular Absorbency Tampons

DEVICE

Tampon CR

Reference Regular Absorbency Tampons

DEVICE

Tampon BS

Modified Super Absorbency Tampons

DEVICE

Tampon CS

Reference Super Absorbency Tampons

Sponsors & Collaborators

  • Kimberly-Clark Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-21
Primary Completion
2023-05-05
Completion
2023-05-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553600 on ClinicalTrials.gov