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About
This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.
Full description
Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.
Enrollment
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Inclusion and exclusion criteria
Main inclusion criteria:
Main exclusion criteria :
Primary purpose
Allocation
Interventional model
Masking
90 participants in 3 patient groups
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Central trial contact
Jean-Paul Deslypere, MD
Data sourced from clinicaltrials.gov
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