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NCT05665569 · ClinicalTrials.gov registry record · NA
Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
A NA study, sponsored by Vaginal Biome Science.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT05665569: Clinical Trial NA study, sponsored by Vaginal Biome Science.
NCT05665569 is a NA study that was terminated before completion, run by Vaginal Biome Science. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05665569, a NA study, was terminated before completion, sponsored by Vaginal Biome Science.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce tissue inflammation faster than women who do not use a vaginal hygiene system to improve their microbiome? Over a 3-month period, participants will be assessed three times for: * vaginal microbiome * vaginal pH * pelvic muscle strength * pelvic muscle tension * vulvovaginal tissue color At each of these 3 assessments, women will answer questions on a questionnaire. Half of the women will be asked to use a vaginal hygiene system at home during these 3 months. Researchers will compare use of a three-product vaginal hygiene system plus a specific vaginal lubricant to see if using these products improves the vaginal microbiome and the pelvic floor outcomes listed above.
Primary Outcome
Vaginal microbiome composition will be assessed by whole-genome sequencing at three timepoints; this outcome assesses the initial 6-week time period. Individual biomes will be categorized as healthy, intermediate, or unhealthy using the VALENCIA model to assign community state types (CSTs). CSTs I, II, and V are "healthy"; CST III is "intermediate"; CST IV is "unhealthy". Changes over time will be analyzed by Krusal-Wallis.
Interventions
- DEVICE Flourish HEC, which contains BioNourish
- OTHER Routine pelvic physical therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2023-03-29 |
| Phase | NA |
Why NCT05665569 stopped before completion
NCT05665569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Flourish HEC, which contains BioNourish is the first listed.
NCT05665569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05665569 about?
NCT05665569 is a clinical study titled "Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders". The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce ...
What is the current status of trial NCT05665569?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2023-01-30. Estimated completion is 2023-03-29.
What interventions are being tested in trial NCT05665569?
The interventions under investigation include: Flourish HEC, which contains BioNourish (DEVICE), Routine pelvic physical therapy (OTHER).
Who is sponsoring clinical trial NCT05665569?
This trial is sponsored by Vaginal Biome Science, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05665569's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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