Phase 4
N=28
Examining the Impact of Tampon Use on the Vaginal Microbiota
Vaginal Microbiota
Bottom Line
View on ClinicalTrials.gov: NCT03346759 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change in Relative Abundance of Lactobacillus Species — .0084; -.0014; -.00004; .0104 relative abundance
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tampon A (Device); Tampon B (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Relative Abundance of Lactobacillus Species |
.0084; -.0014; -.00004; .0104; -.0350; .0238 | — |
| SECONDARY Change in Relative Abundance of Gardnerella Vaginalis |
.000046; 0; -.000045; 0; -.000045; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03346759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.