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

Last updated: June 12, 2023
Sponsor: FEMPHARMA Kft.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Candidemia/candidiasis

Systemic Fungal Infections

Sexually Transmitted Diseases (Stds)

Treatment

JUVIA zinc containing vaginal gel treatment

Fluconazole 150Mg Tab

Clinical Study ID

NCT05895162
2023VVC
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Healthy, nonpregnant female participants aged ≥18 years with a clinical diagnosis ofsymptomatic acute VVC.
  • Positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealingfilamentous hyphae/pseudohyphae or budding yeast cells.
  • Presence of ≥1 vulvovaginal sign.
  • Presence of ≥1 vulvovaginal symptom.
  • Composite Candida severity score of ≥4.

Exclusion

Exclusion Criteria:

  • Abnormal Papanicolaou smear in the preceding 12 months.
  • Patients who had oral or intravenous antifungal agents within 4 weeks, or used topicalvaginal antifungal drugs within 1 week before the study.
  • Known human immunodeficiency virus infection,
  • Liver disease or abnormal liver function tests, lactation, pregnancy, and allergy toazole agents or zinc.
  • Women with non-albicans Candida species will be excluded from the final data analysis.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: JUVIA zinc containing vaginal gel treatment
Phase:
Study Start date:
June 10, 2023
Estimated Completion Date:
January 07, 2025

Study 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.

Connect with a study center

  • Dr. Secret Private Clinic

    Debrecen, HB 4032
    Hungary

    Active - Recruiting

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