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

Maastricht University Medical Centre (MUMC)

Status and phase: Enrolling; Phase 3

Conditions: Recurrent Candidiasis of Vagina; Candidiasis, Vulvovaginal

Treatments: Device: L-Mesitran; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05367089

NL73974.068.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Fluconazole

Active Comparator group

Description:

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.

Treatment:

Drug: Fluconazole

L-Mesitran

Experimental group

Description:

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.

Treatment:

Device: L-Mesitran