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

Hospital Authority, Hong Kong

Status: Completed

Conditions: Impotence; Prostatic Hyperplasia

Treatments: Drug: Vardenafil 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00517179

CRE-2006.017-T

HARECCTR0500057

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind