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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000718-63 | EudraCT Number |
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The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clotrimazole tablet (Canesten, BAY-B5097) | Active Comparator | Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). |
|
| Clotrimazole ovule (Canesten, BAY-B5097) | Experimental | Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clotrimazole, vaginal ovule | Drug | Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) | |
| Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clotrimazole, vaginal tablet | Drug | Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0). |
|
| Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) |
| Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14) | 10-14 days after treatment (=visit 2) |
| Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8) | 6-8 weeks after treatment (=visit 3) |
| München |
| Bavaria |
| 80333 |
| Germany |
| München | Bavaria | 85356 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 22159 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 22359 | Germany |
| Frankfurt am Main | Hesse | 65929 | Germany |
| Fulda | Hesse | 36037 | Germany |
| Wiesbaden | Hesse | 65197 | Germany |
| Hanover | Lower Saxony | 30459 | Germany |
| Osnabrück | Lower Saxony | 49074 | Germany |
| Dortmund | North Rhine-Westphalia | 44319 | Germany |
| Krefeld | North Rhine-Westphalia | 47799 | Germany |
| Moscow | 117198 | Russia |
| Moscow | 119002 | Russia |
| Moscow | 119049 | Russia |
| Moscow | 127473 | Russia |
| Moscow | 129090 | Russia |
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |