Examining the Impact of Tampon Use on the Vaginal Microbiota

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-09-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for one of the first two menstrual cycles during the study. Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the other of the first two menstrual cycle during the study. Subjects used tampons A and B in a randomly assigned order. Subjects then used tampons of their choosing for the third menstrual cycle of the study.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tampon A First

Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.

Group Type EXPERIMENTAL

Tampon A

Intervention Type DEVICE

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

Tampon B

Intervention Type DEVICE

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

Tampon B First

Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.

Group Type EXPERIMENTAL

Tampon A

Intervention Type DEVICE

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

Tampon B

Intervention Type DEVICE

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

Interventions

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Tampon A

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

Intervention Type DEVICE

Tampon B

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* regular menstrual cycles lasting 21-35 days
* menses lasting for at least 4 days
* current tampon user
* good self-reported general health
* good self-reported vaginal health

Exclusion Criteria

* currently pregnant
* planning to become pregnant in 4 months following enrollment
* difficulty using tampons
* current toxic shock syndrome
* history of toxic shock syndrome
* current sexually transmitted infection
* current urinary tract infection
* currently using antibiotics
* antibiotic use in 4 weeks prior to enrollment
* current antifungal use
* antifungal use in 4 weeks prior to enrollment
* autoimmune condition

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes