NCT05367089 The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
| NCT ID | NCT05367089 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Maastricht University Medical Center |
| Condition | Candidiasis, Vulvovaginal |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2026-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 252 participants in total. It began in 2022-08-22 with a primary completion date of 2026-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to investigate the efficacy of Fluconazol versus L-Mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. Vaginal swabs will be analyzed after 1, 6 and 12 months. The study ends after 252 included patients completed the study.
Eligibility Criteria
Inclusion Criteria: * Women of at least 18 years old * Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year) * Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation * Capacity to understand, consent, and comply with the trial procedures Exclusion Criteria: * Mixed vaginal infections * Pregnancy or the intention to become pregnant during the study period * Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion * Known allergies or contra-indications for Fluconazole or honey * Candida with resistance for Fluconazole * Women giving breastfeeding
Frequently Asked Questions
Who can join the NCT05367089 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Candidiasis, Vulvovaginal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05367089 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 252 participants.
Is NCT05367089 currently recruiting?
Yes, NCT05367089 is actively recruiting participants. Visit ClinicalTrials.gov or contact Maastricht University Medical Center to inquire about joining.
Where is the NCT05367089 trial being conducted?
This trial is being conducted at Heerlen, Netherlands, Maastricht, Netherlands.
Who is sponsoring the NCT05367089 clinical trial?
NCT05367089 is sponsored by Maastricht University Medical Center. The trial plans to enroll 252 participants.