NCT05367089

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Candidiasis, Vulvovaginal
• Recurrent Candidiasis of Vagina

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-22
• Primary completion: 2026-04-22
• Completion: 2027-04-22
• First posted: 2022-05-10
• Last updated: 2023-05-17

Locations

2 sites across 1 country: Netherlands