RecruitingNot ApplicableNCT06983041

Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)

Sponsor

Coologics, Inc

Enrollment

55 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Vulvovaginal Candidiasis (VVC)Yeast Vaginitis

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.

Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying vaginal cooling device for people with vulvovaginal candidiasis (vvc) and yeast vaginitis. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 22 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEvaginal cooling device

medical grade polymer capsule filled with inert fluid (15 cc's)

Locations(10)

Symphony Clinical Research

Jacksonville, Florida, United States

Nova Clinical Research

Miami, Florida, United States

Pivotal Clinical Research & Associates

Smyrna, Georgia, United States

Renew Health Clinical Research

Snellville, Georgia, United States

Leavitt Clinical Research

Idaho Falls, Idaho, United States

Next Innovative Clinical Research

Chicago, Illinois, United States

Unified Women's Clinical Research-Raleigh

Raleigh, North Carolina, United States

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Aviati Health

Memphis, Tennessee, United States

Vilo Research Group, Inc.

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06983041

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