Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668135

Enrollment

348

Registered

2008-04-29

Start date

2003-03-31

Completion date

2004-04-30

Last updated

2014-12-17

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

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Interventions

DRUGVardenafil (Levitra, BAY38-9456)

Vardenafil 10 mg orally on demand prior to intercourse

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age: 20 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 * Other

Design outcomes

Primary

Measure	Time frame
International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)	12 weeks

Secondary

Measure	Time frame
Global Assessment Question	12 weeks
Other diary responses	12 weeks
Safety and tolerability	12 weeks

Countries

Hong Kong, Indonesia, Malaysia, Philippines, Singapore, Thailand

Outcome results

None listed

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