Status:
RECRUITING
The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Zuyderland Medical Centre
Conditions:
Candidiasis, Vulvovaginal
Recurrent Candidiasis of Vagina
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT05367089
Start Date
August 22 2022
End Date
April 22 2027
Last Update
May 17 2023
Active Locations (2)
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1
Zuyderland Medical Centre
Heerlen, Netherlands
2
MaastrichtUMC
Maastricht, Netherlands