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

Phase 3

Recruiting

• Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina
• Interventions: Device: L-Mesitran; Drug: Fluconazole

• Registration Number: NCT05367089
• Lead Sponsor: Maastricht University Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2022-04-28
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-10
• Study Start: 2022-08-22
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Primary Completion: 2026-04-22
• Study Completion: 2027-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Mesitran	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.
Fluconazole	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.

Primary Outcome Measures

Name	Time	Method
vaginal swab	12 months	The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. However, the long term cure (after 6 months) will also be evaluated using vaginal swabs in which the presence or absence of microorganisms will be analyzed in the laboratory (mycological cure).

Secondary Outcome Measures

Name	Time	Method
Side effects of medication will be determined with questionnaires	12 months	Information about side effects, discomfort, quality of life and therapy compliance for both treatments will be collected and compared. These parameters will be evaluated using the questionnaires (open questions).
Quality of life will be determined with questionnaires	12 months	The secondary objectives are to investigate the effects of both treatments on the symptoms, including redness, irritation, itching, dysuria, dyspareunia, vaginal discharge, after 1, 6, 9, and 12 months of therapy. In addition, the prophylactic activity after 6 months maintenance treatment, and the long-term efficacy as number of relapses within 12 months will be investigated. These parameters will be evaluated using the questionnaires asking the severity, frequency and duration of each parameter.

Trial Locations

Locations (2)

Zuyderland Medical Centre; 🇳🇱 Heerlen, Netherlands

MaastrichtUMC; 🇳🇱 Maastricht, Netherlands