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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
219
Matching placebo
5m, 10 mg and 20 mg 1 h prior to sexual intercourse
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Laguna Hills, California, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Trumbull, Connecticut, United States
Unnamed facility
Aventura, Florida, United States
Unnamed facility
Lawrenceville, New Jersey, United States
Unnamed facility
Poughkeepsie, New York, United States
Unnamed facility
Statesville, North Carolina, United States
...and 2 more locations
Erection Quality Scale
Time frame: Week 8
Erection Quality Scale
Time frame: Week 4 and 8
International Index of Erectile Function- Erectile Function domain score
Time frame: Week 4 and 8
Per-subject success rates based on Sexual Encounter Profile, Question 2
Time frame: Week 4, 8 Week 8
Safety and tolerability
Time frame: Week 8
Patient Diary Questions
Time frame: Weeks 4, 8 Week 8
Global Assessment Question (GAQ)
Time frame: Weeks 4, 8 of treatment and Week 8
Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
Time frame: Week 8-LOCF
Penetration (SEP2) and Maintenance (SEP3) reliability
Time frame: Week 8-LOCF
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