Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo |
| |
| Levitra (Vardenafil, BAY38-9456) |
| Measure | Description | Time Frame |
|---|---|---|
| Erection Quality Scale | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Erection Quality Scale | Week 4 and 8 | |
| International Index of Erectile Function- Erectile Function domain score | Week 4 and 8 | |
| Per-subject success rates based on Sexual Encounter Profile, Question 2 |
Not provided
Inclusion Criteria:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85023 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
5m, 10 mg and 20 mg 1 h prior to sexual intercourse |
|
| Week 4, 8 Week 8 |
| Safety and tolerability | Week 8 |
| Patient Diary Questions | Weeks 4, 8 Week 8 |
| Global Assessment Question (GAQ) | Weeks 4, 8 of treatment and Week 8 |
| Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) | Week 8-LOCF |
| Penetration (SEP2) and Maintenance (SEP3) reliability | Week 8-LOCF |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Laguna Hills | California | 92653 | United States |
| Newport Beach | California | 92660 | United States |
| Aurora | Colorado | 80012 | United States |
| Trumbull | Connecticut | 06611 | United States |
| Aventura | Florida | 33180 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Statesville | North Carolina | 28677 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Nashville | Tennessee | 37203 | United States |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
Not provided
Not provided