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Completed

NCT Number: NCT00517179

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

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.

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Key information

Conditions

Prostatic Hyperplasia Erectile Dysfunction Genital Diseases Genital Diseases, Male Impotence Male Urogenital Diseases Mental Disorders Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vardenafil 10mg

Drug

Primary outcomes

  1. 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

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 16, 2007
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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