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Examining the Impact of Tampon Use on the Vaginal Microbiota

NCT03346759 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-08-23

Study results available
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Summary

The vaginal microbiota is the community of bacteria in the vagina. The composition of the vaginal microbiota (which bacteria are present and how many of each are present) is known to affect vaginal health and contribute to the development of bacterial vaginosis (the largest cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also known that the composition of the vaginal microbiota changes across a menstrual cycle with the largest changes happening during a woman's period. However, it is not know how tampon use affects vaginal microbiota composition. This study is being done to learn what effect tampon use has on vaginal microbiota composition during a woman's period and between periods.

Conditions

  • Vaginal Microbiota

Interventions

DEVICE

Tampon A

24 Tampax Pearl Regular Tampons for use during a single menstrual period.

DEVICE

Tampon B

24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.

Sponsors & Collaborators

Principal Investigators

  • Jason Bell, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2017-09-11
Completion
2017-09-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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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 NCT03346759 on ClinicalTrials.gov