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Examining the Impact of Tampon Use on the Vaginal Microbiota

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ClinicalTrials.gov Identifier: NCT03346759
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : July 20, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jason Bell, MD, MPH, MS, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Vaginal Microbiota Device: Tampon A Device: Tampon B Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Examining the Impact of Tampon Use on the Vaginal Microbiota
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : September 11, 2017
Actual Study Completion Date : September 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346759


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jason Bell, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by Jason Bell, MD, MPH, MS, University of Michigan:

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Responsible Party: Jason Bell, MD, MPH, MS, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03346759     History of Changes
Other Study ID Numbers: HUM00122922
First Posted: November 17, 2017    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: August 23, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jason Bell, MD, MPH, MS, University of Michigan:
tampon
menstruation
menstrual period