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NCT05573334 · ClinicalTrials.gov registry record · NA
Vaginal Care System for Menopausal Women With Urinary Tract Infections
A NA study, sponsored by Vaginal Biome Science.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT05573334: Completed NA study, sponsored by Vaginal Biome Science.
NCT05573334 is a NA study that has completed, run by Vaginal Biome Science. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573334, a NA study, has completed, sponsored by Vaginal Biome Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to the urethra, this vaginal microbiome shift contributes to a loss of protection against urinary tract infections (UTIs). The investigators are asking whether improving the vaginal microbiome using an over-the-counter vaginal hygiene system can reduce frequency of recurrent UTI in menopausal women.
Primary Outcome
The vaginal microbiome will be assessed using a whole-genome sequencing method at baseline, 3 months, and 6 months. Each measurement will be assigned to one of several "community state types" (CSTs). This outcome examines whether vaginal microbiome shifts from unhealth (CST IV) to intermediate (CST III) or healthy (CST I, II, or V) types over time. This is a three-way repeated measures analysis using study arm, time, and level of CST (healthy, intermediate, unhealthy) as factors.
Interventions
- DEVICE BioNourish
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2025-12-08 |
| Phase | NA |
What the finished NCT05573334 record still lists
NCT05573334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which BioNourish is the first listed.
NCT05573334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05573334 about?
NCT05573334 is a clinical study titled "Vaginal Care System for Menopausal Women With Urinary Tract Infections". Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to the urethra, this vagina...
What is the current status of trial NCT05573334?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2023-07-10. Estimated completion is 2025-12-08.
What interventions are being tested in trial NCT05573334?
The interventions under investigation include: BioNourish (DEVICE).
Who is sponsoring clinical trial NCT05573334?
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 NCT05573334's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 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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