Clinical trial NCT00665340: Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 219
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Erection Quality Scale
timeFrame: Week 8
Secondary outcomes:
measure: Erection Quality Scale
timeFrame: Week 4 and 8
measure: International Index of Erectile Function- Erectile Function domain score
timeFrame: Week 4 and 8
measure: Per-subject success rates based on Sexual Encounter Profile, Question 2
timeFrame: Week 4, 8 Week 8
measure: Safety and tolerability
timeFrame: Week 8
measure: Patient Diary Questions
timeFrame: Weeks 4, 8 Week 8
measure: Global Assessment Question (GAQ)
timeFrame: Weeks 4, 8 of treatment and Week 8
measure: Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)
timeFrame: Week 8-LOCF
measure: Penetration (SEP2) and Maintenance (SEP3) reliability
timeFrame: Week 8-LOCF
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Lawrenceville
country: United States
state: New Jersey
city: Poughkeepsie
country: United States
state: New York
city: Statesville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: