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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo
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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, 10, or 20 mg Vardenafil tablets orally prior to sexual activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| LOCF improved compared to baseline GAQ results at the end of the study | baseline versus visit 2 visit 5 or premature termination visit |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF scores | visits 3, 4 and 5 | |
| OF, SD, IS scores in IIEF Questionnaire | visits 2, 3, 4, 5 or at premature termination visit | |
| Scores of all individual questions on IIEF questionnaire |
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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 |
|---|---|---|---|---|---|---|
| Adana | 01330 | Turkey (Türkiye) | ||||
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Matching placebo tablets orally prior to sexual activity |
|
| visits 2, 3, 4, 5 or at premature termination visit |
| Subject's diary response | baseline and after randomization per visit period |
| SSES-E scores | visits 2 and 5 or premature termination visit |
| Summary score from the responses to SSES-E | visits 2 and 5 or premature termination visit |
| Response scores and summary score from the responses to the SF-36 | visits 2 and 5 or premature termination visit |
| Ankara |
| 06100 |
| Turkey (Türkiye) |
| Ankara | 06500 | Turkey (Türkiye) |
| Antalya | 07003 | Turkey (Türkiye) |
| Istanbul | 34098 | Turkey (Türkiye) |
| Istanbul | 34662 | Turkey (Türkiye) |
| Izmir | 35340 | Turkey (Türkiye) |
| Samsun | 55139 | Turkey (Türkiye) |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |