Recurrent vulvovaginal candidiasis Recurrent vaginal fungal infection
Conditions
Interventions
Intervention 1: Fluconazole (Diflucan®). Therapy according to manufacturer*s
instructions.
As treatment for active RVVC: each patient will receive 3 capsules (150 mg), 1
capsule on day 1, 1 capsule
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Mixed vaginal infections • Pregnancy or the intention to become pregnant during the study period • Women using systemic or topical antifungal medication during the last two weeks prior to inclusion • Known allergies or containdications for Fluconazole or honey • Candida with resistance for Fluconazole • Women giving breastfeeding
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to investigate the effects of both treatments on the clinical 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 therapy, and the long-term efficacy as number of relapses within 12 months will be investigated. Moreover, information about side effects, discomfort, quality of life, therapy compliance, and cost of treatments for both products will be collected and compared. Furthermore, we will analyze the vaginal microbiota (by vaginal self-swabs) to study the effect of MGH on the vaginal microenvironment. | — |
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the vaginal culture after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups. Since the number of relapses is important for investigating the long-term efficacy, the follow-up period will be 12 months. | — |
Countries
Netherlands
Contacts
Public ContactSJJM van Riel
Maastricht Universitair Medisch Centrum +
Outcome results
None listed