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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-001228-37 |
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This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.
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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 |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo | 24 weeks | |
| Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo | 24 weeks |
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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 |
|---|---|---|---|---|---|---|
| Bruxelles - Brussel | 1000 | Belgium | ||||
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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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|
| Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) | 24 weeks |
| Genk |
| 3600 |
| Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Roeselare | 8800 | Belgium |
| La Rochelle | 17000 | France |
| Lille | 59000 | France |
| Lyon | 69000 | France |
| Marseille | 13009 | France |
| Marseille | 13275 | France |
| Mont-de-Marsan | 40000 | France |
| Paris | 75009 | France |
| Toulouse | 31000 | France |
| Hamburg | Hamburg / 287 | 20251 | Germany |
| Hamburg | Hamburg / 287 | 20354 | Germany |
| Hamburg | Hamburg / 287 | 22177 | Germany |
| Hanover | Niedersachsen / 291 | 30625 | Germany |
| Brühl | Nordrhein-Westfalen / 325 | 50321 | Germany |
| Mülheim | Nordrhein-Westfalen / 481 | 45468 | Germany |
| Wuppertal | Nordrhein-Westfalen / 616 | 42103 | Germany |
| Bautzen | Sachsen / 313 | 02625 | Germany |
| Dresden | Sachsen / 313 | 01129 | Germany |
| Leipzig | Sachsen / 313 | 04105 | Germany |
| Leisnig | Sachsen / 313 | 04703 | Germany |
| Meißen | Sachsen / 313 | 01662 | Germany |
| Wahlstedt | Schleswig-Holstein / 306 | 23812 | Germany |
| Bergamo | 24128 | Italy |
| Florence | 50139 | Italy |
| Milan | 20132 | Italy |
| Naples | 80131 | Italy |
| Roma | 00155 | Italy |
| Arnhem | 6836 BH | Netherlands |
| Deventer | 7415 EH | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Nijverdal | 7442 LS | Netherlands |
| Bloemfontein | Free State | 9324 | South Africa |
| Johannesburg | Gauteng | 2090 | South Africa |
| Durban | KwaZulu-Natal | 4037 | South Africa |
| Durban | KwaZulu-Natal | 4091 | South Africa |
| Newcastle | KwaZulu-Natal | 2940 | South Africa |
| Alicante | Alicante | 03010 | Spain |
| Barcelona | Barcelona | 08034 | Spain |
| La Roca del Vallès | Barcelona | 08430 | Spain |
| Barcelona | Catalonia | 08025 | Spain |
| Vigo | Pontevedra | 36211 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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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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