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NCT06983041 · ClinicalTrials.gov registry record · NA
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
A NA study of Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis, sponsored by Coologics.
- Recruiting
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 10
- Study locations
NCT06983041: Recruiting NA study of Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis, sponsored by Coologics.
NCT06983041 is a NA study of Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis that is actively recruiting participants, run by Coologics. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06983041, a NA study of Vulvovaginal Candidiasis (VVC) and Yeast Vaginitis, is actively recruiting participants, sponsored by Coologics.
- RECRUITING
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 10
- Study locations
Study Summary
The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.
Primary Outcome
VSS of 0-1(based on severity of infection), KOH negative for Hyphae
Conditions Studied
Interventions
- DEVICE vaginal cooling device
Study Locations (10)
Florida
- Symphony Clinical Research - Jacksonville
- Nova Clinical Research - Miami
Georgia
- Pivotal Clinical Research & Associates - Smyrna
- Renew Health Clinical Research - Snellville
North Carolina
- Unified Women's Clinical Research-Raleigh - Raleigh
- Lyndhurst Clinical Research - Winston-Salem
Idaho
- Leavitt Clinical Research - Idaho Falls
Illinois
- Next Innovative Clinical Research - Chicago
Tennessee
- Aviati Health - Memphis
Texas
- Vilo Research Group, Inc. - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT06983041 shows while recruiting
NCT06983041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Vulvovaginal Candidiasis (VVC) appearing as the primary indexed condition, and to 1 intervention - of which vaginal cooling device is the first listed.
NCT06983041 lists 10 locations in 7 states (Florida, Georgia, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06983041 about?
NCT06983041 is a clinical study titled "Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)". The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-...
What is the current status of trial NCT06983041?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2025-05-22. Estimated completion is 2026-06-30.
What conditions does trial NCT06983041 study?
This clinical trial studies the following conditions: Vulvovaginal Candidiasis (VVC), Yeast Vaginitis.
What interventions are being tested in trial NCT06983041?
The interventions under investigation include: vaginal cooling device (DEVICE).
Who is sponsoring clinical trial NCT06983041?
This trial is sponsored by Coologics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06983041 being conducted?
This trial has 10 study locations across Florida, Georgia, Idaho, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06983041's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 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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