Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656188
• Other study ID #: 10898
• Secondary ID: GSK 001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2008
• Last updated: October 9, 2013
• Start date: October 2002
• Est. completion date: May 2003

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,

• History of unresponsiveness to sildenafil

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/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 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse
• Placebo
Matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function domain of the International Index of Erectile Function		12 weeks	No
Primary	Sexual Encounter Profile Question 2		12 weeks	No
Primary	Sexual Encounter Profile Question 3		12 weeks	No
Secondary	Erectile Function domain scores > 26		12 weeks	No
Secondary	Sexual Encounter Profile 2		12 weeks	No
Secondary	Global Assessment Question		12 weeks	No
Secondary	Reliability of insertion		12 weeks	No
Secondary	Reliability of maintenance		12 weeks	No
Secondary	Other subject diary based variables		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes

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