Status:

COMPLETED

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

Lead Sponsor:

Samsung Medical Center

Conditions:

Benign Prostatic Hyperplasia

Eligibility:

MALE

50+ years

Phase:

NA

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 ...

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00730418

Start Date

January 1 2007

End Date

March 1 2010

Last Update

August 26 2010

Active Locations (1)

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Samsung Medical Center

Seoul, South Korea, 135-710