The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
466
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Unnamed facility
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Unnamed facility
München, Bavaria, Germany
Unnamed facility
München, Bavaria, Germany
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Time frame: 10-14 days after treatment (=visit 2)
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Time frame: 6-8 weeks after treatment (=visit 3)
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Unnamed facility
Hamburg, Free and Hanseatic City of Hamburg, Germany
Unnamed facility
Hamburg, Free and Hanseatic City of Hamburg, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Fulda, Hesse, Germany
Unnamed facility
Wiesbaden, Hesse, Germany
Unnamed facility
Hanover, Lower Saxony, Germany
Unnamed facility
Osnabrück, Lower Saxony, Germany
...and 7 more locations