Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656188

Enrollment

463

Registered

2008-04-10

Start date

2002-10-31

Completion date

2003-05-31

Last updated

2013-10-10

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 tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 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

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * History of unresponsiveness to sildenafil * Stable sexual relationship for \> 6 month

Exclusion criteria

* Primary hypoactive sexual desire * History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * Nitrate therapy

Design outcomes

Primary

Measure	Time frame
Erectile Function domain of the International Index of Erectile Function	12 weeks
Sexual Encounter Profile Question 2	12 weeks
Sexual Encounter Profile Question 3	12 weeks

Secondary

Measure	Time frame
Reliability of insertion	12 weeks
Reliability of maintenance	12 weeks
Erectile Function domain scores > 26	12 weeks
Safety and tolerability	12 weeks
Other subject diary based variables	12 weeks
Sexual Encounter Profile 2	12 weeks
Global Assessment Question	12 weeks

Outcome results

None listed

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