Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-49
SponsorCoologics, Inc
About this trial
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 criteria
Qualifiers
Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.
Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC.
Able to read and understand English.
Able to provide written informed consent and to understand and agree to all study procedures required.
Disqualifiers
1. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.
Trial design
Treatments tested in this trial
- vaginal cooling device
Treatment groups
55 Participants
are divided into 1 treatment groupLocations
10Florida
Symphony Clinical Research32224, Jacksonville United States
Nova Clinical Research33162, Miami United States
Georgia
Pivotal Clinical Research & Associates30082, Smyrna United States
Renew Health Clinical Research30078, Snellville United States
Sponsors and collaborators
Coologics, Inc
Lead sponsor
Source ClinicalTrials.gov