Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction

Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681772

Enrollment

333

Registered

2008-05-21

Start date

2003-03-31

Completion date

2003-11-30

Last updated

2014-12-11

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

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5mg, 10mg or 20mg taken 1 hours before sexual 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

* Men \>/= 18 years of age, * ED 6 months or longer * 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 * Other

Design outcomes

Primary

Measure	Time frame
International Index of Erectile Function - Erectile Function Domain	12 weeks

Secondary

Measure	Time frame
Sexual Encounter Profile Question 2 and 3	12 weeks
Global Assessment Question	12 weeks
Other diary based variables	12 weeks
Safety and tolerability	12 weeks

Outcome results

None listed

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