Study Evaluating the Efficacy and Safety of Flexible-dose 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 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658177

Enrollment

463

Registered

2008-04-14

Start date

2003-06-30

Completion date

2004-02-29

Last updated

2014-12-02

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

Study to investigate the efficacy and safety of Vardenafil

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

20mg to be taken 1 h 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 * Other

Design outcomes

Primary

Measure	Time frame
Sexual Encounter Profile Question 2	12 weeks

Secondary

Measure	Time frame
Internation Index of Erectile Function-Erectile Function domain	12 weeks
Safety and tolerability	12 weeks
Sexual Encounter Profile Question 3	12 weeks

Outcome results

None listed

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