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Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.
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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 | 5 mg, 10 mg and 20 mg one hour prior to sexual intercourse |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function - Erectile Function Domain | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Questionnaire | 12 weeks | |
| IIEF-EF domain score | 12 weeks | |
| Other diary based variables |
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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 |
|---|---|---|---|---|---|---|
| Alicante | Alicante | 03010 | Spain | |||
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| Placebo |
| Drug |
Matching placebo |
|
| 12 weeks |
| Safety and tolerability | 12 weeks |
| Sabadell |
| Barcelona |
| 08208 |
| Spain |
| Barcelona | Catalonia | 08025 | Spain |
| Granada | Granada | 18003 | Spain |
| Hondarribia | Guipuzcoa | 28280 | Spain |
| Leganés | Madrid | 28911 | Spain |
| Móstoles | Madrid | 28935 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Vigo | Pontevedra | 36211 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Seville | Sevilla | 41071 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Valladolid | Valladolid | 47011 | Spain |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| 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 |
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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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