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

Not Applicable

Completed

• Conditions: Impotence; Prostatic Hyperplasia

• Registration Number: NCT00517179
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study Completion: 2007-05
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China