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

• Status: Recruiting
• Trial end date: 2025-01-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FEMPHARMA Kft.
• Treatments: Fluconazole

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.