CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Tampon A +1 moredevice
Likely dose
24 tampons per menstrual period (brand-specific: Tampax Pearl Regular or Playtex Gentle Glide 360 Regular)AI-extracted
Key inclusion· 5
  • Regular menstrual cycles lasting 21–35 days
  • Menstrual periods lasting at least 4 days
  • Current tampon user
  • Good self-reported general health
Key exclusion· 7
  • Currently pregnant or planning pregnancy within 4 months of enrollment
  • Difficulty using tampons
  • Current or history of toxic shock syndrome
  • Current sexually transmitted infection or urinary tract infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03346759
NCT03346759Phase 4Completed

Examining the Impact of Tampon Use on the Vaginal Microbiota

University of Michigan·interventional·Posted Nov 17, 2017·Updated Aug 23, 2018

In Brief

A Phase 4 clinical trial evaluating Tampon A and Tampon B for Vaginal Microbiota. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartFeb 20, 2017
Primary CompletionSep 11, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.6 years ago

Interventions

Tampon Adevice

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

Tampon Bdevice

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