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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Coologics, Inc
Study ID
NCT06983041
Status
Recruiting
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Conditions

  • Vulvovaginal Candidiasis (VVC)
  • Yeast Vaginitis

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • vaginal cooling device — DEVICE
    medical grade polymer capsule filled with inert fluid (15 cc's)

Study Details

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.

Key Dates

Start date
May 22, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: uncomplicated vulvovaginal candidiasis
    Twice daily use of vaginal cooling device for 30 minutes a time for three days (i.e., 3 hours total) in female subjects with VVC age 22-49 (inclusive).

Primary Outcome Measure

Number of clinical cures at 7 days [ Time Frame: 7 days (+/-2) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Symphony Clinical ResearchJacksonvilleFlorida32224
Christian Hering
[email protected]
8134305500
Nancy Slay
[email protected]
Daniel McDyer, MD (PRINCIPAL_INVESTIGATOR)
Nova Clinical ResearchMiamiFlorida33162
Lashaun Sanders, RN
[email protected]
3054071822
Christ-Ann Maglorie, MD (PRINCIPAL_INVESTIGATOR)
Pivotal Clinical Research & AssociatesSmyrnaGeorgia30082
Willisha Johnson
[email protected]
770-376-7912
Melinda Miller-Thrasher, MD (PRINCIPAL_INVESTIGATOR)
Renew Health Clinical ResearchSnellvilleGeorgia30078
Javonte Maynor
[email protected]
770-833-0616
Pharonda Lee
[email protected]
Tyndal Jones, MD (PRINCIPAL_INVESTIGATOR)
Leavitt Clinical ResearchIdaho FallsIdaho83404-
Next Innovative Clinical ResearchChicagoIllinois60616
LaToya Hinton
[email protected]
(708) 955-7856
Imani Gardner
[email protected]
Monica Moore, MD (PRINCIPAL_INVESTIGATOR)
Unified Women's Clinical Research-RaleighRaleighNorth Carolina27607
Cassie Harris
[email protected]
919-788-4449
Ann Collins, MD (PRINCIPAL_INVESTIGATOR)
Lyndhurst Clinical ResearchWinston-SalemNorth Carolina27103
Madelyn Biffle
[email protected]
336 397 3716
Robert Parker, MD (PRINCIPAL_INVESTIGATOR)
Aviati HealthMemphisTennessee38115-
Vilo Research Group, Inc.HoustonTexas77070
Jorge Mendez
[email protected]
832-660-5095
Tamara Sanchez
[email protected]
Elvis Massip Perez, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

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Symphony Clinical Research· Jacksonville, FLNova Clinical Research· Miami, FLPivotal Clinical Research & Associates· Smyrna, GARenew Health Clinical Research· Snellville, GALeavitt Clinical Research· Idaho Falls, IDNext Innovative Clinical Research· Chicago, IL

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