Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786253
• Other study ID #: 11875
• Secondary ID: EudraCT No: 2005
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2008
• Last updated: October 27, 2014
• Start date: October 2005
• Est. completion date: January 2007

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use
• Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	SEP 2		12- 24 weeks	No
Secondary	SEP 3		12- 24 weeks	No

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