NCT03346759

Examining the Impact of Tampon Use on the Vaginal Microbiota

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-09-11
• Completion: 2017-09-11
• First posted: 2017-11-17
• Last updated: 2018-08-23
• Results posted: 2018-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study