The Effect of Medical Grade Honey Formulation (L-Mesitran) Administration on Recurrent Vulvovaginal Candidiasis Symptoms
Recruiting
Phase 3
Interventional Study
Candidiasis, Vulvovaginal
Recurrent Candidiasis of Vagina
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 252 (estimated)
- Sponsor
- Maastricht University Medical Center · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 c…
Contacts
No contact information available.