Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00682019

Enrollment

383

Registered

2008-05-21

Start date

2003-12-31

Completion date

2004-08-31

Last updated

2013-10-14

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

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5mg, 10mg or 20mg taken 8 hours before 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
Per-patient success rates based on Sexual Encounter Profile, Question 3	10 weeks

Secondary

Measure	Time frame
Per-subject success rates based on Sexual Encounter Profile, Question 2	10 weeks
International Index of Erectile Function- Erectile Function domain score	10 weeks
Global Assessment Question (GAQ)	10 weeks
Safety and tolerability	10 weeks

Outcome results

None listed

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