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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 31, 2025 to Jun 30, 2026
    • Study sites: 5 to 10
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Jul 31, 2025 to Oct 31, 2025
    • Study completion date: Aug 31, 2025 to Dec 31, 2025
    • Start date changed from estimate of May 19, 2025 to May 22, 2025
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06983041
Lead Sponsor Coologics, Inc
Conditions
(from sponsor)		 Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
Related terms Candidiasis, Vulvovaginal
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov