Candidiasis, Vulvovaginal, Recurrent Candidiasis of Vagina
Conditions
Keywords
Treatment, L-Mesitran, Fluconazol, Vaginal swabs
Brief summary
The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.
Interventions
DRUGFluconazole
Fluconazol once a month 150 mg capsule
OTHERL-Mesitran
The first month apply every day one sachet, the next five months apply every week one sachet.
Sponsors
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
Yes
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 for Fluconazole or honey * Candida with resistance for Fluconazole
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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life will be termined with questionnaires | 1 month | The secondary objectives are to investigate the effects of both treatments on the clinical cure rate and 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. They will reach from no complaints-a little bit-moderate-severe |
| Side effect of medication will be termined with questionnaires | 1 month | The secondary objectives are to investigate the effects of both treatments on the clinicalcure rate and 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. |
Outcome results
None listed