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NCT04118049 · ClinicalTrials.gov registry record · NA
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
A NA study, sponsored by Hartford Hospital.
- Completed
- Registry status
- NA
- Development phase
- 141
- Enrollment target
NCT04118049: Completed NA study, sponsored by Hartford Hospital.
NCT04118049 is a NA study that has completed, run by Hartford Hospital. The registered enrollment target is 141 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04118049, a NA study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
Study Summary
In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).
Primary Outcome
Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.
Interventions
- OTHER Standard Care
- OTHER BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2021-05-30 |
| Phase | NA |
What the finished NCT04118049 record still lists
NCT04118049 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT04118049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04118049 about?
NCT04118049 is a clinical study titled "Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment". In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory...
What is the current status of trial NCT04118049?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2019-10-30. Estimated completion is 2021-05-30.
What interventions are being tested in trial NCT04118049?
The interventions under investigation include: Standard Care (OTHER), BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel. (OTHER).
Who is sponsoring clinical trial NCT04118049?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04118049's enrollment target sits among peer trials
141 712th of 2000 higher than 1,288 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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