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

NCT ID: NCT05895162

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2025-01-07

Brief 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.

Detailed Description

Randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc-containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4-8-12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow-ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in-office evaluation.

Conditions

Vulvovaginal Candidiasis; Vaginal Yeast Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JUVIA zinc-containing vaginal gel and Fluconazole

JUVIA zinc containing vaginal gel group. Receive oral fluconazole treatment (150 mg) and after that participants will use a zinc containing- vaginal gel for 12 weeks.

Group Type: EXPERIMENTAL

JUVIA zinc containing vaginal gel treatment

Intervention Type: DRUG

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).

Fluconazole 150Mg Tab

Intervention Type: DRUG

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

Fluconazole

Control group. Receive oral fluconazole treatment.

Group Type: ACTIVE_COMPARATOR

Fluconazole 150Mg Tab

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Fluconazole 150Mg Tab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

FEMPHARMA Kft.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bence Kozma, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dr. Secret Private Clinic Debrecen Hungary

Locations

Dr. Secret Private Clinic

Debrecen, HB, Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Szilvia Jager, PhD

Role: CONTACT

szilvia.jager@fempharma.hu

0036 203926655

Facility Contacts

Bence Kozma, MD PhD

Role: primary

bence.kozma@med.unideb.hu

0036 703263596

Other Identifiers

2023VVC

Identifier Type: -

Identifier Source: org_study_id