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

Bayer129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

129

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

Alicante, Alicante, Spain

Unnamed facility

Sabadell, Barcelona, Spain

Unnamed facility

Barcelona, Catalonia, Spain

Unnamed facility

Granada, Granada, Spain

Outcomes

Primary Outcomes

International Index of Erectile Function - Erectile Function Domain

Time frame: 12 weeks

Secondary Outcomes

Global Assessment Questionnaire

Time frame: 12 weeks

IIEF-EF domain score

Time frame: 12 weeks

Other diary based variables

Time frame: 12 weeks

Safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

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