check_circleStudy Completed
Clotrimazole, Ovulen, Vulvovaginal Candidiasis
Bayer Identifier:
13071
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Comparative efficacy of ovule vs tablet
Trial purpose
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
Key Participants Requirements
Sex
FemaleAge
14 - 50 YearsTrial summary
Enrollment Goal
466Trial Dates
September 2008 - May 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Clotrimazole (BAYB5097)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Frauenarztpraxis Dr. M. Baumgärtner | München, 80333, Germany |
Completed | Praxis Hr. Dr. H. Frommeyer | Osnabrück, 49074, Germany |
Completed | Praxis Dr. Larbig | Fulda, 36037, Germany |
Completed | Praxis Dr. S. Clauss-Hoffmann | Frankfurt, 65929, Germany |
Completed | Praxis Hr. Dr. Johannes Brücker | Dortmund, 44319, Germany |
Terminated | Praxis Hr. Dr. Adrian Flohr | Krefeld, 47799, Germany |
Completed | Moscow State Institute of Public Health | Moscow, 119049, Russia |
Completed | Russian University of Peoples' Friendship | Moscow, 117198, Russia |
Completed | Kliniken und Polikliniken der Albert-Ludwigs-Universität | Freiburg, 79106, Germany |
Completed | Praxis Hr. Dr. L. Baumgartner | München, 85356, Germany |
Completed | Praxis Hr. Dr. K. Greven | Hannover, 30459, Germany |
Completed | Praxis Hr. Dr. K. Peters | Hamburg, 22159, Germany |
Completed | Praxis Hr. Dr. T. Gent | Hamburg, 22359, Germany |
Completed | Praxis fr. Dr. G. Simko-Leonhard | Wiesbaden, 65197, Germany |
Completed | Moscow State Medical Stomatological University | Moscow, 127473, Russia |
Completed | Institute State Federal Policlinic no 1 | Moscow, 119002, Russia |
Completed | Polyclinic N 3 of RF President Administrative Dept. | Moscow, 129090, Russia |
Completed | Russian State Medical University RSMU | Moscow, 129090, Russia |
Terminated | Russian University of Peoples' Friendship | Moscow, 117198, Russia |
Completed | Russian State Medical University RSMU, Moscow, Hospital №31 | Moscow, 129090, Russia |
Primary Outcome
- Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)date_rangeTime Frame:10-14 days after treatment (=visit 2)
Secondary Outcome
- Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)date_rangeTime Frame:6-8 weeks after treatment (=visit 3)
- Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)date_rangeTime Frame:10-14 days after treatment (=visit 2)
- Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)date_rangeTime Frame:6-8 weeks after treatment (=visit 3)
- Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)date_rangeTime Frame:10-14 days after treatment (=visit 2)
- Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)date_rangeTime Frame:6-8 weeks after treatment (=visit 3)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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