Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina
Conditions
Keywords
L-Mesitran, Fluconazol, vaginal swabs, medical grade honey, antifungal activity
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.
Interventions
DRUGFluconazole
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.
DEVICEL-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.
Sponsors
Zuyderland Medical Centre
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vaginal swab | 1 month | The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran) and control (Diflucan) groups. The vaginal swab will be analyzed in the laboratory to determine the presence or absence of microorganisms and thus the mycological cure rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life will be determined with questionnaires | 1 month | 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. |
| Side effects of medication will be determined with questionnaires | 1 month | 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). |
Countries
Netherlands
Outcome results
None listed