A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

Bayer260 enrolled

Overview

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

PlaceboDRUG

Matching Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance * Heterosexual relationship for more than 6 months * Partner willing to complete the TSS 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 according to the Summary of Product Characteristics

Locations (38)

Unnamed facility

Outcomes

Primary Outcomes

Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.

Time frame: 16 weeks

Secondary Outcomes

International Index of Erectile Function

Time frame: 16 weeks

Treatment Satisfaction Scale

Time frame: 16 weeks

Other patient diary based variables

Time frame: 16 weeks

Safety and tolerability

Time frame: 16 weeks

Data from ClinicalTrials.gov

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