Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661596
• Other study ID #: 11139
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: December 28, 2014
• Start date: May 2003
• Est. completion date: January 2004

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: 18 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 exclusion criteria apply acc. to Summary of Product Characteristics

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)
5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
• Placebo
Matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function - Erectile Function Domain		12 weeks	No
Secondary	Global Assessment Questionnaire		12 weeks	No
Secondary	IIEF-EF domain score		12 weeks	No
Secondary	Other diary based variables		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes

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