Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730418

Enrollment

Registered

2008-08-08

Start date

2007-01-31

Completion date

2010-03-31

Last updated

2010-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor

Brief summary

In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed description

To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as * Real-time RT-PCR * Radioligand receptor binding * Western blot * Immunohistochemistry

Interventions

DRUGDoxazosin

Treatment with doxazosin 4mg daily for 24 mos

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* 50 yrs or greater * International prostatic symptom score \>= 8 * Maximal flow rate \< 15mL/sec * baseline PSA 2.5-10 ng/mL * Pathologically proven BPH * No medication history for BPH * Able to give fully informed consent

Exclusion criteria

* Previous use of alpha-blocker, 5-alpha reductase inhibitor * Previous surgery for BPH * Urologic cancer history * Urethral stricture * baseline PSA \> 10ng/mL * BP \< 90/70 mmHg * Orthotopic hypotension with syncope * Serum Cr \> 2.0 mg/dl, alanine aminotransferase \> 1.5 times of normal limit * Bacterial prostatitis within 1 year * Urinary tract infection(UTI) more than 2 times within 1 year * Active UTI or prostate biopsy within 1 month * Unable to void * Ped use because of incontinence * Hypersensitivity to alpha-blocker that include quinazoline * Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months * Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.) * Psychiatric problem * Alcohol abuse or other drug abuse history * Severe comorbidities unable to perform long-term trial * seems not to be appropriate to this study because of any other reasons

Design outcomes

Primary

Measure	Time frame
Expression of alpha-1 adrenoceptor	before treatment and 12mos and 24 mos after treatment

Secondary

Measure	Time frame
International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events	before treatment and 3mos, 12mos, and 24mos after treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026