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| ID | Type | Description | Link |
|---|---|---|---|
| LV0901 | Other Identifier | Company internal |
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The primary goal of this international non-interventional study is to investigate the therapeutic effectiveness of vardenafil (film-coated tablet) in Erectile Dysfunction patients with the Metabolic Syndrome in daily clinical practice. It will include a large number of patients with various underlying conditions with different cultural and demographic backgrounds from different geographic areas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | Drug | Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with a clinically relevant, intra-individual improvement in erectile function defined as an increase of 4 points in the erectile function domain of the International Index of Erectile Function (IIEF) | After approx 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with an increase of 5 points in the Erectile Dysfunction domain of the IIEF after approx. 12 weeks | After approx. 12 weeks | |
| Subjects with normal erectile function (IIEF-EF ³26) After approx. 12 weeks | After approx. 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Egypt | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27151768 | Result | Shabsigh R, Mattern A; REVITALISE Study Group. REVITALISE: A Large Observational Study Assessing the Safety and Effectiveness of Vardenafil in Men With Erectile Dysfunction and Metabolic Syndrome. Sex Med. 2016 Sep;4(3):e135-44. doi: 10.1016/j.esxm.2016.03.027. Epub 2016 Apr 14. |
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| Subjects with mild Erectile Dysfunction (IIEF-EF 22-25) After approx. 12 weeks | After approx. 12 weeks |
| Optional by country, the effect of vardenafil on health-related quality of life (HRQoL) using the Aging Males Symptoms (AMS) Scale | After approx. 12 weeks |
| Many Locations |
| Israel |
| Many Locations | Kazakhstan |
| Many Locations | Kyrgyzstan |
| Many Locations | Lebanon |
| Many Locations | Russia |
| Many Locations | Saudi Arabia |
| Many Locations | Singapore |
| Many Locations | South Korea |
| Many Locations | Ukraine |
| 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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