Clinical trial NCT03346759: Examining the Impact of Tampon Use on the Vaginal Microbiota
Official title: Examining the Impact of Tampon Use on the Vaginal Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Microbiota
Keywords: tampon
menstruation
menstrual period
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in Relative Abundance of Lactobacillus Species
timeFrame: 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:
measure: Change in Relative Abundance of Gardnerella Vaginalis
timeFrame: 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)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jason Bell, MD
role: PRINCIPAL_INVESTIGATOR
References: