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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00755053 |
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Clotrimazole Ovulen Vulvovaginal Candidiasis |
Drug: Clotrimazole, vaginal ovule Drug: Clotrimazole, vaginal tablet |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 466 |
| Study Start Date: | September 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Clotrimazole, vaginal ovule
1 dose of 500 mg Clotrimazole administered intravaginally as an ovule
|
| Active Comparator: Arm 2 |
Drug: Clotrimazole, vaginal tablet
1 dose of 500 mg Clotrimazole administered intravaginally as a tablet
|
Eligibility| Ages Eligible for Study: | 14 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| München, Bayern, Germany, 80333 | |
| München, Bayern, Germany, 85356 | |
| Frankfurt, Hessen, Germany, 65929 | |
| Fulda, Hessen, Germany, 36037 | |
| Wiesbaden, Hessen, Germany, 65197 | |
| Hannover, Niedersachsen, Germany, 30459 | |
| Osnabrück, Niedersachsen, Germany, 49074 | |
| Dortmund, Nordrhein-Westfalen, Germany, 65197 | |
| Krefeld, Nordrhein-Westfalen, Germany, 47799 | |
| Hamburg, Germany, 22159 | |
| Hamburg, Germany, 22359 | |
| Russian Federation | |
| Moscow, Russian Federation, 117415 | |
| Moscow, Russian Federation, 117198 | |
| Moscow, Russian Federation, 117997 | |
| Moscow, Russian Federation, 119002 | |
| Moscow, Russian Federation, 129090 | |
| Moscow, Russian Federation, 127473 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Consumer Care Inc. |
| ClinicalTrials.gov Identifier: | NCT00755053 History of Changes |
| Other Study ID Numbers: | 13071, EudraCT Nr: 2008-000718-63 |
| Study First Received: | September 17, 2008 |
| Last Updated: | June 15, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Russia: Ministry of Health and Social Development of the Russian Federation |
|
Clotrimazole Ovule Tablet Vulvovaginal candidiasis Non-inferiority |
|
Candidiasis Candidiasis, Vulvovaginal Mycoses Vulvovaginitis Vaginitis Vaginal Diseases Genital Diseases, Female Vulvitis Vulvar Diseases Clotrimazole |
Miconazole Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents |