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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Prostatic Hyperplasia Impotence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vardenafil 10mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No