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RECRUITING
NCT06983041
NA

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

Sponsor: Coologics, Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

22 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2025-05-22

Completion Date

2026-06-30

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DEVICE

vaginal 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