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Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | Drug | 10 mg one hour prior to sexual intercourse |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual encounter profile question 2 | 4 weeks | |
| Hardness of erection | 4 weeks | |
| Other diary based variables |
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Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruxelles - Brussel | 1070 | Belgium | ||||
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| Tadalafil |
| Drug |
10 mg taken approximately 24 hours prior to sexual intercourse |
|
| 4 weeks |
| Safety and tolerability | 4 weeks |
| Bruxelles - Brussel |
| 1200 |
| Belgium |
| Edegem | 2650 | Belgium |
| Roeselare | 8800 | Belgium |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Medellín | Colombia |
| Santa Fé de Bogotá | Colombia |
| Helsinki | 00100 | Finland |
| Helsinki | 00180 | Finland |
| Oulu | 90100 | Finland |
| Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Stuttgart | Baden-Wurttemberg | 70372 | Germany |
| Königsbrunn | Bavaria | 86343 | Germany |
| München | Bavaria | 80333 | Germany |
| München | Bavaria | 81925 | Germany |
| Weiden | Bavaria | 92637 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20354 | Germany |
| Marburg | Hesse | 35039 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Osnabrück | Lower Saxony | 49076 | Germany |
| Westerstede | Lower Saxony | 26655 | Germany |
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
| Berlin | State of Berlin | 13125 | Germany |
| Berlin | State of Berlin | 13347 | Germany |
| Berlin | State of Berlin | 13465 | Germany |
| Haifa | Israel | 31096 | Israel |
| Jerusalem | Israel | 91120 | Israel |
| Tel Aviv | Israel | 64239 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Catania | 95124 | Italy |
| Milan | 20123 | Italy |
| Milan | 20132 | Italy |
| Milan | 20142 | Italy |
| Padova | 35128 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06126 | Italy |
| Pisa | 56126 | Italy |
| Durango | Durango | 34000 | Mexico |
| Iguala de la Independencia | Guerrero | 40000 | Mexico |
| México, D. F. | México, D. F. | 06700 | Mexico |
| Monterrey | Nuevo León | 66260 | Mexico |
| México, D.F. | 14050 | Mexico |
| México, D.F. | 14080 | Mexico |
| Nijverdal | 7442 LS | Netherlands |
| Utrecht | 3514 AB | Netherlands |
| Moelv | 2390 | Norway |
| Oslo | 0272 | Norway |
| Sarpsborg | 1700 | Norway |
| Trondheim | 7006 | Norway |
| Callao | CALLAO 2 | Peru |
| Lima | 33 | Peru |
| Lima | LIMA 27 | Peru |
| George | Eastern Cape | 6530 | South Africa |
| Johannesburg | Gauteng | 2193 | South Africa |
| Pretoria | Gauteng | 0083 | South Africa |
| Durban | KwaZulu-Natal | 3630 | South Africa |
| Durban | KwaZulu-Natal | 4000 | South Africa |
| Durban | KwaZulu-Natal | 4091 | South Africa |
| Newcastle | KwaZulu-Natal | 2940 | South Africa |
| Pietermaritzburg | KwaZulu-Natal | 3200 | South Africa |
| Cape Town | Western Cape | 7505 | South Africa |
| Cape Town | Western Cape | 7800 | South Africa |
| A Coruña | A Coruña | 15006 | Spain |
| Sant Joan d'Alacant | Alicante | 03550 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Castellon | Castellón de La Plana | 12004 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Palma de Mallorca | Palma de Mallorca | 07014 | Spain |
| Vigo | Pontevedra | 36211 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Borås | 503 32 | Sweden |
| Skövde | 541 30 | Sweden |
| Stockholm | 171 76 | Sweden |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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