Vulvovaginal CandidiasisNCT05895162
Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.
A study testing JUVIA zinc containing vaginal gel treatment and Fluconazole 150Mg Tab in people with Vulvovaginal Candidiasis and Vaginal Yeast Infections, run by FEMPHARMA Kft. at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis, Vaginal Yeast Infections
- What is being tested?
- JUVIA zinc containing vaginal gel treatment and Fluconazole 150Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHungary
- Study dates
- 10 Jun 2023to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.
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.
Read the 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
- Being tested
- JUVIA zinc containing vaginal gel treatment, Fluconazole 150Mg Tab
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Fluconazole 150Mg TabDrug
Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JUVIA zinc containing vaginal gel treatment; Drug: Fluconazole 150Mg Tab |
| Fluconazole | Active comparator | Control group. Receive oral fluconazole treatment. Receives: Drug: Fluconazole 150Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (13)
Time to initial symptom resolution.
Measured: 12 weeks
Vaginal fungal culture for Candida species.
Proportion of negative vaginal fungal culture for Candida species.
Measured: 12 weeks
Clinical cure at days 28, 56, 84
The proportion of participants with clinical cure at days 28, 56, 84. 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 (at days 28, 56, 84).
Measured: 12 weeks
Candida severity score
Minimum score: 0; maximum score: 18; higher score worse outcome.
Measured: 12 weeks
PRA-1 level
Measured: 12 weeks
CVL zinc level
Measured: 12 weeks
Vaginal pH
Measured: 12 weeks
Vaginal neutrophil count
Measured: 12 weeks
Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA
Measured: 12 weeks
Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR
Measured: 12 weeks
Vulvovaginal symptoms questionnaire
Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms
Measured: 12 weeks
Vaginal Health Index
Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms
Measured: 12 weeks
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start10 Jun 2023
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- FEMPHARMA Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bence Kozma, MD PhD, Principal investigator, Dr. Secret Private Clinic Debrecen Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895162
- Sponsor's protocol ID
- 2023VVC
- Status last verified
- Aug 2026
- First submitted
- 15 May 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kunkli A, Ratonyi D, Kozma B, Farkas B, Majoros L, Poka R, Sipos AG, Takacs P, Krasznai ZT, Kozma B. Cervicovaginal zinc and copper profiles across vaginitis phenotypes and hydrogel assignment: an exploratory pilot study. BMC Womens Health. 2026 Aug 1;26(1):566. doi: 10.1186/s12905-026-04768-6.
PubMed 42947086Roselletti E, Kozma B, Ratonyi D, Kunkli A, Kozma B, Takacs P, Wilson D. Vaginal PRA1 identifies clinically relevant Candida albicans vaginitis and excludes asymptomatic colonization: an exploratory study. BMC Microbiol. 2026 Jul 17. doi: 10.1186/s12866-026-05405-w. Online ahead of print.
PubMed 42464124
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.
- ClinicalTrials.gov ID
- NCT05895162
- Acronym / sponsor ID
- 2023VVC
- Conditions
- Vulvovaginal Candidiasis, Vaginal Yeast Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- FEMPHARMA Kft.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVIA zinc-containing vaginal gel and Fluconazole | Experimental | Drug: JUVIA zinc containing vaginal gel treatment, Drug: Fluconazole 150Mg TabJUVIA 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. |
| Fluconazole | Active comparator | Drug: Fluconazole 150Mg TabControl group. Receive oral fluconazole treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUVIA zinc containing vaginal gel treatmentWomen 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 | JUVIA zinc-containing vaginal gel and Fluconazole |
| Fluconazole 150Mg TabWomen receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg). | Drug | Fluconazole, JUVIA zinc-containing vaginal gel and Fluconazole |
Primary outcome
Clinical cure
Time frame: 12 weeks
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.
13 secondary outcomes
Time to initial symptom resolution.
Time frame: 12 weeks
Vaginal fungal culture for Candida species.
Time frame: 12 weeks
Clinical cure at days 28, 56, 84
Time frame: 12 weeks
Candida severity score
Time frame: 12 weeks
PRA-1 level
Time frame: 12 weeks
CVL zinc level
Time frame: 12 weeks
Vaginal pH
Time frame: 12 weeks
Vaginal neutrophil count
Time frame: 12 weeks
Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA
Time frame: 12 weeks
Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR
Time frame: 12 weeks
Vulvovaginal symptoms questionnaire
Time frame: 12 weeks
Vaginal Health Index
Time frame: 12 weeks
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42947086Kunkli A, Ratonyi D, Kozma B, Farkas B, Majoros L, Poka R, Sipos AG, Takacs P, Krasznai ZT, Kozma B. Cervicovaginal zinc and copper profiles across vaginitis phenotypes and hydrogel assignment: an exploratory pilot study. BMC Womens Health. 2026 Aug 1;26(1):566. doi: 10.1186/s12905-026-04768-6.
- Derived from this study: PubMed 42464124Roselletti E, Kozma B, Ratonyi D, Kunkli A, Kozma B, Takacs P, Wilson D. Vaginal PRA1 identifies clinically relevant Candida albicans vaginitis and excludes asymptomatic colonization: an exploratory study. BMC Microbiol. 2026 Jul 17. doi: 10.1186/s12866-026-05405-w. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bence Kozma, MD PhD principal investigator
Dr. Secret Private Clinic Debrecen Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVIA zinc containing vaginal gel treatment and Fluconazole 150Mg Tab in people with Vulvovaginal Candidiasis and Vaginal Yeast Infections, run by FEMPHARMA Kft. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.