NCT05553600

Tampon Design Validation Study

An Open-Label Clinical Validation Study of an Applicator Tampon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Kimberly-Clark Corporation · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-10-21
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2022-09-23
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study