A Randomized Controlled Trial: the Effect of a Medical Grade Honey Formulation (L-Mesitran) on Clinical Symptoms of Recurrent Vulvovaginal Candidiasis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Zuyderland Medical Centre
RECRUITING
Heerlen
MaastrichtUMC
RECRUITING
Maastricht
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2027-04-22
Participants
Target number of participants: 252
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Zuyderland Medical Centre