Examining the Impact of Tampon Use on the Vaginal Microbiota

NCT03346759 | Completed Phase 4 Results FDA Device

• 1 other identifier: HUM00122922
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Microbiota

Keywords

tampon; menstruation; menstrual period

Outcome Measures

Primary Outcomes (1)

• Change in Relative Abundance of Lactobacillus Species

  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.

  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)

Secondary Outcomes (1)

• Change in Relative Abundance of Gardnerella Vaginalis

  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)

Study Arms (2)

Tampon A First

EXPERIMENTAL

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; Device: Tampon B

Tampon B First

EXPERIMENTAL

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; Device: Tampon B

Interventions

Tampon A DEVICE

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

Tampon A First; Tampon B First

Tampon B DEVICE

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

Tampon A First; Tampon B First

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Results Point of Contact

• Title: Jason Bell, MD
• Organization: University of Michigan

jasonbel@med.umich.edu

7342323897

Study Officials

• Jason Bell, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 17, 2017
• Study Start: February 20, 2017
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2017
• Last Updated: August 23, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-07

Locations

US (1)