Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661297

Enrollment

523

Registered

2008-04-18

Start date

2003-06-30

Completion date

2004-01-31

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)

10 mg Vardenafil to be taken 1 h prior to sexual attempt

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

* Heterosexual males * \>/= 18 years old with ED for more than six months * Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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 (SEP 2)	12 weeks

Secondary

Measure	Time frame
Sexual Encounter Profile question 3 (SEP 3)	12 weeks
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain	12 weeks
Safety and Tolerability	12 weeks

Outcome results

None listed

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