Zinc gel and fluconazole for treating vaginal yeast infections
Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.
NA · FEMPHARMA Kft. · NCT05895162
This study is testing if adding a zinc gel to the usual fluconazole treatment can help women with vaginal yeast infections feel better and prevent them from coming back.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | FEMPHARMA Kft. (industry) |
| Locations | 1 site (Debrecen, HB) |
| Trial ID | NCT05895162 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a zinc-containing vaginal gel and oral fluconazole in treating vulvovaginal candidiasis (VVC) and preventing its recurrence. A total of 76 healthy, nonpregnant women aged 18 and older with symptomatic acute VVC will be randomly assigned to receive either fluconazole alone or fluconazole followed by the zinc gel treatment. Participants will undergo clinical assessments and laboratory tests at baseline and during follow-up visits to monitor symptoms and infection recurrence. The study seeks to determine if the addition of zinc gel can reduce reinfection rates compared to standard fluconazole treatment alone.
Who should consider this trial
Good fit: Ideal candidates are healthy, nonpregnant women aged 18 and older with symptomatic acute vulvovaginal candidiasis.
Not a fit: Patients with non-albicans Candida species or those with recent antifungal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of vaginal yeast infections in women.
How similar studies have performed: While the use of zinc in vaginal treatments is not widely studied, similar approaches have shown promise in managing recurrent infections.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Debrecen, HB
- Dr. Secret Private Clinic — Debrecen, HB, Hungary (RECRUITING)
Study contacts
- Principal investigator: Bence Kozma, MD PhD — Dr. Secret Private Clinic Debrecen Hungary
- Study coordinator: Szilvia Jager, PhD
- Email: szilvia.jager@fempharma.hu
- Phone: 0036 203926655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vulvovaginal Candidiasis, Vaginal Yeast Infections