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| ID | Type | Description | Link |
|---|---|---|---|
| REPEAT | Other Identifier | Company Internal | |
| LV0602 | Other Identifier | Company Internal | |
| 12942 - LV0602KR | Other Identifier | Company Internal | |
| 12975 - LV0602HR | Other Identifier | Company Internal | |
| 12976 - LV0602CN | Other Identifier | Company Internal | |
| 12977 - LV0602SG | Other Identifier | Company Internal | |
| 13047 - LV0602SE | Other Identifier | Company Internal | |
| 13048 - LV0602ZA | Other Identifier | Company Internal | |
| 13067 - LV0602HU | Other Identifier | Company Internal | |
| 13093 - LV0602MY | Other Identifier | Company Internal | |
| 13112 - LV0602ID | Other Identifier | Company Internal | |
| 13208 - LV0602TH | Other Identifier | Company Internal | |
| 13416 - LV0602ES | Other Identifier | Company Internal | |
| 13417 - LV0602SA | Other Identifier | Company Internal | |
| 13600 - LV0602PL | Other Identifier | Company Internal | |
| 14525 - LV0602FR | Other Identifier | Company Internal |
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The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | Drug | Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's assessment of safety (incidence of adverse events) | During observation period |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of ED symptoms | End of study | |
| General quality of partnership as assessed by patient | Initial visit and after 3, 6, 9 and 12 months | |
| General quality of partnership as assessed by partner |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of erectile dysfunction 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 | China | |||||
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| Initial visit and after 3, 6, 9 and 12 months |
| Many Locations |
| Croatia |
| Many Locations | France |
| Many Locations | Germany |
| Many Locations | Hungary |
| Many Locations | Indonesia |
| Many Locations | Malaysia |
| Many Locations | Poland |
| Many Locations | Saudi Arabia |
| Many Locations | Singapore |
| Many Locations | South Africa |
| Many Locations | South Korea |
| Many Locations | Spain |
| Many Locations | Sweden |
| Many Locations | Thailand |
| 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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