Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT05895162

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

Conditions: Vulvovaginal Candidiasis, Vaginal Yeast Infections

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: FEMPHARMA Kft.

Location: Dr. Secret Private Clinic Debrecen HB

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.

Eligibility Criteria

Inclusion Criteria: * Healthy, nonpregnant female participants aged ≥18 years with a clinical diagnosis of symptomatic acute VVC. * Positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae/pseudohyphae or budding yeast cells. * Presence of ≥1 vulvovaginal sign. * Presence of ≥1 vulvovaginal symptom. * Composite Candida severity score of ≥4. Exclusion Criteria: * Abnormal Papanicolaou smear in the preceding 12 months. * Patients who had oral or intravenous antifungal agents within 4 weeks, or used topical vaginal antifungal drugs within 1 week before the study. * Known human immunodeficiency virus infection, * Liver disease or abnormal liver function tests, lactation, pregnancy, and allergy to azole agents or zinc. * Women with non-albicans Candida species will be excluded from the final data analysis.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05895162). StuddyBuddy aggregates publicly available trial information.