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OpenTrials
Completed

NCT Number: NCT03346759

Examining the Impact of Tampon Use on the Vaginal Microbiota

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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Key information

Conditions

Vaginal Microbiota

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tampon A

Device

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

Tampon B

Device

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

Primary outcomes

  1. Change in Relative Abundance of Lactobacillus Species

    Time frame: Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)

    The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.

Secondary outcomes

  1. Change in Relative Abundance of Gardnerella Vaginalis

    Time frame: Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)

    The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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