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NCT05478746 · ClinicalTrials.gov registry record · NA
Effects of Flourish HEC on Localized Provoked Vulvodynia
A NA study, sponsored by Vaginal Biome Science.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05478746: Completed NA study, sponsored by Vaginal Biome Science.
NCT05478746 is a NA study that has completed, run by Vaginal Biome Science. The registered enrollment target is 7 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
NCT05478746, a NA study, has completed, sponsored by Vaginal Biome Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study is designed to determine whether improving the vaginal microbiome in women with localized provoked vulvodynia (LPV) may help improve pain better than routine care alone. The study randomizes women with LPV to either routine care or routine care plus a vaginal hygiene system designed to improve the vaginal microbiome. Women will be assessed for vaginal microbiome, vaginal pH, and pain before enrollment and after 6 weeks, and after 3 months. Women will also have pain assessed 2 weeks after enrollment without assessing vaginal microbiome and pH.
Primary Outcome
Using whole-genome sequencing, all microbes present in the vaginal microbiome will be identified and reported for relative abundance.
Interventions
- DEVICE BioNourish, a component of the Flourish HEC kit
- OTHER Control - no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2024-01-15 |
| Phase | NA |
What the finished NCT05478746 record still lists
NCT05478746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 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 BioNourish, a component of the Flourish HEC kit is the first listed.
NCT05478746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05478746 about?
NCT05478746 is a clinical study titled "Effects of Flourish HEC on Localized Provoked Vulvodynia". This study is designed to determine whether improving the vaginal microbiome in women with localized provoked vulvodynia (LPV) may help improve pain better than routine care alone. The study randomizes women with LPV to either routine care or routine care plus a vaginal hygiene system designed to im...
What is the current status of trial NCT05478746?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2022-09-26. Estimated completion is 2024-01-15.
What interventions are being tested in trial NCT05478746?
The interventions under investigation include: BioNourish, a component of the Flourish HEC kit (DEVICE), Control - no intervention (OTHER).
Who is sponsoring clinical trial NCT05478746?
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 NCT05478746's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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