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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hungary
Dr. Secret Private Clinic
RECRUITING
Debrecen
Contact Information
Primary
Szilvia Jager, PhD
szilvia.jager@fempharma.hu
0036 203926655
Time Frame
Start Date: 2023-06-10
Completion Date: 2025-01-07
Participants
Target number of participants: 76
Treatments
Experimental: 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.
Active_comparator: Fluconazole
Control group. Receive oral fluconazole treatment.
Related Therapeutic Areas
Sponsors
Leads: FEMPHARMA Kft.

This content was sourced from clinicaltrials.gov

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