NCT05895162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

May 15, 2023

Last Update Submit

June 12, 2023

Conditions

Vulvovaginal CandidiasisVaginal Yeast Infections

Outcome Measures

Primary Outcomes (1)

  • Clinical cure

    The proportion of participants with clinical cure throughout the study period. Clinical cure is defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period.

    12 weeks

Secondary Outcomes (13)

  • Time to initial symptom resolution.

    12 weeks

  • Vaginal fungal culture for Candida species.

    12 weeks

  • Clinical cure at days 28, 56, 84

    12 weeks

  • Candida severity score

    12 weeks

  • PRA-1 level

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

JUVIA zinc-containing vaginal gel and Fluconazole

EXPERIMENTAL

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.

Drug: JUVIA zinc containing vaginal gel treatmentDrug: Fluconazole 150Mg Tab

Fluconazole

ACTIVE COMPARATOR

Control group. Receive oral fluconazole treatment.

Drug: Fluconazole 150Mg Tab

Interventions

JUVIA zinc containing vaginal gel treatmentDRUG

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).

JUVIA zinc-containing vaginal gel and Fluconazole
Fluconazole 150Mg TabDRUG

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

FluconazoleJUVIA zinc-containing vaginal gel and Fluconazole

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Secret Private Clinic

Debrecen, HB, 4032, Hungary

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsVulvovaginitisVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVulvitisVulvar DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bence Kozma, MD PhD

    Dr. Secret Private Clinic Debrecen Hungary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Szilvia Jager, PhD

CONTACT

0036 203926655szilvia.jager@fempharma.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 8, 2023

Study Start

June 10, 2023

Primary Completion

December 31, 2024

Study Completion

January 7, 2025

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

HU(1)