An investigator-blinded, active-controlled phase 3 study to prove the non-inferior efficacy of a Clotrimazole ovule (500 mg) versus a Clotrimazole vaginal tablet (500 mg) in vaginal candidiasis

Update Il y a 4 ans
Reference: EUCTR2008-000718-63

Woman Man

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Extract

non-inferior efficacy in terms of overall response defined as clinical (resolution of clinical signs and symptoms) and mycological cure (negative microscopy and negative culture) 10 to 14 days post application of clotrimazole 500 mg vaginal ovule compared to clotrimazole 500 mg vaginal tablet


Inclusion criteria

  • vaginal candidiasis

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