Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00786253

Enrollment

236

Registered

2008-11-06

Start date

2005-10-31

Completion date

2007-01-31

Last updated

2014-10-28

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

Compare once daily vs on demand treatment in men with erectile dysfunction. Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out: A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Vardenafil 10 mg on demand use

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Males 18-64 years of age * Mild or mild to moderate ED (defined as \>15 and \<21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit) * History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease * Stable, heterosexual relationship for more than six months

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
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)	12- 24 weeks

Secondary

Measure	Time frame
SEP 2	12- 24 weeks
SEP 3	12- 24 weeks

Countries

Germany

Outcome results

None listed

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