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To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
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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 | Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 | At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. |
| Measure | Description | Time Frame |
|---|---|---|
| Success in penetration and maintenance as recorded in subject diaries | At Weeks 4, 8 and 12 (as observed and at LOCF) | |
| Scores for questions 3 and 4 of the IIEF | At Weeks 4, 8 and 12 (as observed and at LOCF) |
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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 |
|---|---|---|---|---|---|---|
| Bangalore | Karnataka | 560010 | India | |||
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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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 | Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks |
|
| Other IIEF domain scores | At Week 12 (observed and at LOCF) |
| Global Assessment Question (GAQ) responses | At Weeks 4, 8 and 12 (as observed and at LOCF) |
| Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. | At Weeks 4, 8 and 12 (as observed and at LOCF) |
| Bangalore |
| Karnataka |
| 560054 |
| India |
| Belagum | Karnataka | 590010 | India |
| Mumbai | Maharashtra | 400007 | India |
| Mumbai | Maharashtra | 400022 | India |
| Madurai | Tamil Nadu | 625107 | India |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010879 |
| Piperazines |