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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.
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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 | 10mg Vardenafil taken orally 1 hour prior to sexual intercourse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of vardenafil on the duration of erection | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of erection to be hard enough for penetration | 4 weeks |
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Inclusion Criteria:- Males with erectile dysfunction- Stable heterosexual relationship Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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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 |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |