NCT05895162

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

Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: FEMPHARMA Kft. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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).
DRUG	Fluconazole 150Mg Tab	Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).

Timeline

• Start date: 2023-06-10
• Primary completion: 2024-12-31
• Completion: 2025-01-07
• First posted: 2023-06-08
• Last updated: 2023-06-13

Locations

1 site across 1 country: Hungary