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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-005282-37 | EudraCT Number |
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Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vardenafil + Placebo | Experimental | Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo. |
|
| Placebo + Vardenafil | Experimental | Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil (Levitra, BAY 38-9456), 10 mg | Drug | 10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests | Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation. | 4 treatment days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo | 4 treatment days | |
| Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo |
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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 |
|---|---|---|---|---|---|---|
| Badalona | Barcelona | 08916 | Spain | |||
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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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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D013119 | Spinal Cord Injuries |
| 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 | 10/20 mg placebo in sequence in respective arm |
|
| Vardenafil (Levitra, BAY 38-9456), 20 mg | Drug | 20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator. |
|
| 4 treatment days |
| Number of participants with adverse events | Approximately 4 weeks |
| Toledo |
| Toledo |
| 45071 |
| Spain |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010879 |
| Piperazines |