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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 is a NA study that has completed, run by Vaginal Biome Science. The registered enrollment target is 7 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05478746
The ClinicalTrials.gov registry entry for NCT05478746 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaginal Biome Science, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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