Examining the Impact of Tampon Use on the Vaginal Microbiota

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Vaginal Microbiota

Treatments: Device: Tampon B; Device: Tampon A

Study type: Interventional

Funder types: Other

Identifiers

NCT03346759

HUM00122922

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Tampon A First

Experimental group

Description:

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.

Treatment:

Device: Tampon A

Device: Tampon B

Tampon B First

Experimental group

Description:

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.

Treatment:

Device: Tampon A

Device: Tampon B