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NCT05701722 · ClinicalTrials.gov registry record · NA
Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome
A NA study, sponsored by Vaginal Biome Science.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05701722: Completed NA study, sponsored by Vaginal Biome Science.
NCT05701722 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
NCT05701722, a NA study, has completed, sponsored by Vaginal Biome Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: * Does using a specific vaginal care system reduce recurrence of BV? * How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: * Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study * Answer questionnaires about vulvovaginal symptoms at each of these three timepoints * Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
Primary Outcome
The number of separate BV episodes will be assessed between baseline and 24 weeks in each arm separately. BV may be diagnosed by clinical test (Aptima, SureSwab, Affirm VPIII, etc.) that is routinely used by the study site; Amsel criteria; and/or Nugent scores. Where there is discordance between tests, the participant will be BV positive if 2/3 tests are positive. BV positive by Amsel criteria include having at least 3 of the following 4 parameters: 1) thin, white-to-gray homogeneous vaginal dis
Interventions
- DEVICE Flourish HEC Vaginal Care System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2024-02-15 |
| Phase | NA |
What the finished NCT05701722 record still lists
NCT05701722 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 1 intervention - of which Flourish HEC Vaginal Care System is the first listed.
NCT05701722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05701722 about?
NCT05701722 is a clinical study titled "Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome". The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: * Does using a specific vaginal care system reduce recurrence of BV? * How does using this vaginal care system change th...
What is the current status of trial NCT05701722?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2023-03-29. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT05701722?
The interventions under investigation include: Flourish HEC Vaginal Care System (DEVICE).
Who is sponsoring clinical trial NCT05701722?
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 NCT05701722'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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