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