Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
Conditions
Keywords
yeast infection
Brief 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.
Interventions
DEVICEvaginal cooling device
medical grade polymer capsule filled with inert fluid (15 cc's)
Sponsors
Coologics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria. 1. Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC. 2. Able to read and understand English. 3. Able to provide written informed consent and to understand and agree to all study procedures required. 4. Has a smart phone and has the ability to access and use the ValidCare app. 5. Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either "negative for intraepithelial lesion or malignancy" or "ASCUS-atypical squamous cells of undetermined significance" and negative for high-risk HPV types or negative colposcopy plus/minus biopsies were performed for high-risk HPV types. 6. Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline. 7. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) of VVC. 8. Presence of at least one vulvovaginal symptom (itching, pain or burning, irritation) 9. Willing and able to avoid vaginal (or any) sexual activity during the study period. 10. Menstrual products such as tampons, pads, and menstrual cups may be used during the study period including before and after device use.
Exclusion criteria
* 1\. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of clinical cures at 7 days | 7 days (+/-2) | VSS of 0-1(based on severity of infection), KOH negative for Hyphae |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | 28 days (+/-2) | VSS of 0-1(based on severity of infection), KOH negative for Hyphae |
Countries
United States
Contacts
CONTACTKimberly J Langdon, MD
CONTACTKeith Aqua, MD
Outcome results
None listed