BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668057

Enrollment

624

Registered

2008-04-28

Start date

2002-12-31

Completion date

2003-09-30

Last updated

2015-03-06

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

Brief summary

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5 mg Vardenafil orally 1 hour prior to sexual intercourse

DRUGPlacebo

5 mg matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. * Stable heterosexual relationship

Exclusion criteria

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4) * Nitrate use * Other

Design outcomes

Primary

Measure	Time frame
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15	12 weeks

Secondary

Measure	Time frame
Global Assessment Questionnaire	12 weeks
Erectile Function domain score of the International Index of Erectile Function	12 weeks
Safety and tolerability	12 weeks

Countries

China

Outcome results

None listed

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