Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661596

Enrollment

129

Registered

2008-04-18

Start date

2003-05-31

Completion date

2004-01-31

Last updated

2014-12-30

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

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age: 18 years and older * Males with erectile dysfunction * Stable heterosexual relationship

Exclusion criteria

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months * Nitrate use * Other

Design outcomes

Primary

Measure	Time frame
International Index of Erectile Function - Erectile Function Domain	12 weeks

Secondary

Measure	Time frame
Global Assessment Questionnaire	12 weeks
IIEF-EF domain score	12 weeks
Other diary based variables	12 weeks
Safety and tolerability	12 weeks

Countries

Spain

Outcome results

None listed

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