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

Hospital Authority, Hong Kong40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatic Hyperplasia Impotence

Interventions

Vardenafil 10mgDRUG

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 50 to 80 years old * Clinically diagnosed to have lower urinary tract symptoms secondary to BPH: 1. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) \>=8 2. Detectable prostatic enlargement determined by Digital Rectum Examination (DRE) 3. 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

Locations (1)

Prince of Wales Hospital

Hong Kong, China

Outcomes

Primary Outcomes

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

Time frame: From half hour prior to till six hour after administration of the drug (baseline)

Secondary Outcomes

Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP)

Time frame: 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

Time frame: From half hour prior to till six hour after administration of the drug (baseline)

Data from ClinicalTrials.gov

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