Overview

Patients With Vulvovaginal Candidiasis

Status:
Unknown status
Trial end date:
2020-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Sao Paulo
Treatments:
Clotrimazole
Miconazole
Criteria
Inclusion Criteria:

-Have performed the clinical and laboratory diagnosis of vulvovaginitis by Candida

Exclusion Criteria:

- cPatients with recurrent candidiasis;

- History of hepatic, renal, hematological, cardiovascular diseases and with
decompensated diabetes mellitus (glycemia above 200) and obesity with BMI above 35);

- Diagnosis of vulvovaginitis by another agent;

- Make use of chronic antimicrobials (informed by the patient)

- Be pregnant

- Allergy to some component of medications given