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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2005-002796-32 |
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Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | Drug | 10 mg Vardenafil bid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score and maximal urinary flow | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score, storing and voiding subscore | 8 weeks | |
| IIEF-EF domains score | 8 weeks | |
| Safety and tolerability |
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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 |
|---|---|---|---|---|---|---|
| Biberach | Baden-Württemberg / 277 | 88400 | 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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| Drug |
Matching placebo |
|
| 8 weeks |
| München |
| Bayern / 280 |
| 81925 |
| Germany |
| Rosenheim | Bayern / 280 | 83022 | Germany |
| Starnberg | Bayern / 280 | 82319 | Germany |
| Weiden | Bayern / 280 | 92637 | Germany |
| Hamburg | Hamburg / 287 | 20251 | Germany |
| Hamburg | Hamburg / 287 | 20354 | Germany |
| Marburg | Hessen / 307 | 35039 | Germany |
| Tostedt | Niedersachsen / 292 | 21255 | Germany |
| Osnabrück | Niedersachsen / 293 | 49076 | Germany |
| Düsseldorf | Nordrhein-Westfalen / 296 | 40210 | Germany |
| Leverkusen | Nordrhein-Westfalen / 331 | 51373 | Germany |
| Mülheim | Nordrhein-Westfalen / 481 | 45468 | Germany |
| Leipzig | Sachsen / 313 | 04105 | Germany |
| Kiel | Schleswig-Holstein / 306 | 24105 | Germany |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D000091662 | Genital Diseases |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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