Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Bayer102 enrolled

Overview

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Erectile Dysfunction

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10mg taken 1 hours before sexual intercourse

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men \>/= 18 years of age * Erectile Dysfunction Exclusion Criteria: * History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * Nitrate therapy * Other exclusion criteria apply according to the Summary of Product Characteristics

Outcomes

Primary Outcomes

International Index of Erectile Function- Erectile Function domain

Time frame: 8 weeks

Secondary Outcomes

Global Assessment Questionnaire (GAQ)

Time frame: 8 weeks

Safety and tolerability

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.