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NCT03346759 · ClinicalTrials.gov registry record · Phase 4
Examining the Impact of Tampon Use on the Vaginal Microbiota
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT03346759: Completed Phase 4 study, sponsored by University of Michigan.
NCT03346759 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03346759, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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. in
Interventions
- DEVICE Tampon A
- DEVICE Tampon B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2017-09-11 |
| Phase | Phase 4 |
What the finished NCT03346759 record still lists
NCT03346759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Tampon A is the first listed.
NCT03346759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03346759 about?
NCT03346759 is a clinical study titled "Examining the Impact of Tampon Use on the Vaginal Microbiota". 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 discharg...
What is the current status of trial NCT03346759?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2017-02-20. Estimated completion is 2017-09-11.
What interventions are being tested in trial NCT03346759?
The interventions under investigation include: Tampon A (DEVICE), Tampon B (DEVICE).
Who is sponsoring clinical trial NCT03346759?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03346759's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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