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

NCT06983041 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-01-30

No results posted yet for this 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.

Conditions

  • Vulvovaginal Candidiasis (VVC)
  • Yeast Vaginitis

Interventions

DEVICE

vaginal cooling device

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

Sponsors & Collaborators

  • Coologics, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983041 on ClinicalTrials.gov