Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665340

Enrollment

219

Registered

2008-04-23

Start date

2004-07-31

Completion date

2005-01-31

Last updated

2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Vardenafil

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.

Interventions

DRUGPlacebo

Matching placebo

DRUGLevitra (Vardenafil, BAY38-9456)

5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Erection Quality Scale	Week 8

Secondary

Measure	Time frame
International Index of Erectile Function- Erectile Function domain score	Week 4 and 8
Per-subject success rates based on Sexual Encounter Profile, Question 2	Week 4, 8 Week 8
Safety and tolerability	Week 8
Erection Quality Scale	Week 4 and 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
Patient Diary Questions	Weeks 4, 8 Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026