Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668018

Enrollment

887

Registered

2008-04-28

Start date

2003-01-31

Completion date

2003-10-31

Last updated

2014-12-23

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

Conditions

Erectile Dysfunction

Keywords

Male Erectile Dysfunction, Vardenafil

Brief summary

Assess efficacy of vardenafil within 6 hours after intake

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Vardenafil 10mg orally on demand prior to intercourse

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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

Design outcomes

Primary

Measure	Time frame
Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake	12 weeks

Secondary

Measure	Time frame
International Index of Erectile Function	12 weeks
Global Assessment Question (GAQ)	12 weeks
Other diary responses	12 weeks
General Safety	12 weeks

Outcome results

None listed

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