Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS

Study Overview
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Brief Summary
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The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.

Official Title
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Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS for the Treatment of Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia, Impotence

Intervention / Treatment
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* Drug: Vardenafil 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 50 to 80 years old Clinically diagnosed to have lower urinary tract symptoms secondary to BPH: Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >=8 Detectable prostatic enlargement determined by Digital Rectum Examination (DRE) Urinary flow between 5 to 15ml/second in a total void volume >=150mL Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score <= 21 Exclusion Criteria: Congestive heart failure, unstable angina, arrhythmia, myocardial infraction Hypertension or on any antihypertensive agents Take nitrate and medication contradicted to vardenafil Uncontrolled or poorly controlled diabetes mellitus Intolerance or contra-indicated for the use of vardenafil Hepatic disorder

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vardenafil 10mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo |  | From half hour prior to till six hour after administration of the drug (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP) |  | From half hour prior to till six hour after administration of the drug (baseline) | 
| Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug |  | From half hour prior to till six hour after administration of the drug (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)