Overview
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.
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.
Eligibility
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