RecruitingPhase 3NCT05367089

The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms

A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis


Sponsor

Maastricht University Medical Center

Enrollment

252 participants

Start Date

Aug 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fluconazole and a medical device called L-Mesitran for people with candidiasis, vulvovaginal and recurrent candidiasis of vagina. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluconazole

Way of administration: oral capsules. One capsule at the same day of the week. Dosage: As treatment for active RVVC- in the first week on day 1 one capsule 150 mg Fluconazole, on day 4 one capsule 150 mg Fluconazole and on day 7 one capsule 150 mg Fluconazole. As prophylaxis to prevent a new RVVC episode: one capsule Fluconazol 150 mg per week for a duration of 6 months.

DEVICEL-Mesitran

Way of administration: intra-vaginal application using an applicator. Dosage: As treatment for active RVVC - Single daily application (5 grams) for 1 month. As prophylaxis to prevent a new RVVC episode: Single weekly (5 grams) application for 5 months.


Locations(2)

Zuyderland Medical Centre

Heerlen, Netherlands

MaastrichtUMC

Maastricht, Netherlands

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NCT05367089


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