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

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

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Vardenafil 10mg

Primary Measures

• 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 Measures

• 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)
    

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Lead Sponsor: Hospital Authority, Hong Kong

Overall Clinical Trial Officials and Contacts

Chi Fai Ng, Dr Principal Investigator Department of Surgery, Division of Urology, The Chinese University of Hong Kong  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00517179

Study ID Number: CRE-2006.017-T

ClinicalTrials.gov Identifier: NCT00517179

Health Authority: Hong Kong: Ethics Committee

HAREC Clinical Trial Registry