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Recruiting NCT05367089

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

Phase III Interventional Candidiasis, Vulvovaginal Recurrent Candidiasis of Vagina

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluconazole, L-Mesitran.
Who it may be relevant to
Registry conditions: Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a Medical Grade Honey formulation (L-Mesitran ®) in relation to the current standard of care (Fluconazole) 1 month after starting treatment in patients with RVCC. As a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. In addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, and quality of life will be collected and compared. The study ends after 252 included patients completed the study.

Interventions

  • Drug Fluconazole
    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.
  • Device L-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.

Primary outcome measures

  • vaginal swab [Time frame: 1 month]
  • vaginal swab [Time frame: 6 months]
  • vaginal swab [Time frame: 12 months]
Secondary outcome measures (8)
  • Quality of life will be determined with questionnaires [Time frame: 1 month]
  • Quality of life will be determined with questionnaires [Time frame: 6 months]
  • Quality of life will be determined with questionnaires [Time frame: 9 months]
  • Quality of life will be determined with questionnaires [Time frame: 12 months]
  • Side effects of medication will be determined with questionnaires [Time frame: 1 month]
  • Side effects of medication will be determined with questionnaires [Time frame: 6 months]
  • Side effects of medication will be determined with questionnaires [Time frame: 9 months]
  • Side effects of medication will be determined with questionnaires [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 2 centers
  • Zuyderland Medical Centre — Heerlen
  • MaastrichtUMC — Maastricht

Publications

  • van Riel SJJM, Lardenoije CMJG, Wassen MMLH, van Kuijk SMJ, Cremers NAJ. Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY). BMJ Open. 2023 Aug 28;13(8):e070466. doi: 10.1136/bmjopen-2022-070466. PMID 37640455

Identifiers

NCT: NCT05367089 · NL73974.068.21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗