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Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.

NCT05895162 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-06-13

No results posted yet for this study

Summary

Vaginitis is one of the most common gynecological problems in women. Candida albicans is responsible for more than 85% of vaginal fungal infections and reinfection after standard treatment is quite common. The aim of this study is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). The investigator's hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

Conditions

  • Vulvovaginal Candidiasis
  • Vaginal Yeast Infections

Interventions

DRUG

JUVIA zinc containing vaginal gel treatment

Women receive a single oral dose of fluconazole (150mg) followed by treatment with JUVIA zinc containing vaginal gel (daily for 2 weeks and twice per week thereafter).

DRUG

Fluconazole 150Mg Tab

Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).

Sponsors & Collaborators

  • FEMPHARMA Kft.

    lead INDUSTRY

Principal Investigators

  • Bence Kozma, MD PhD · Dr. Secret Private Clinic Debrecen Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2024-12-31
Completion
2025-01-07

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05895162 on ClinicalTrials.gov