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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730418
First Posted: August 8, 2008
Last Update Posted: August 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  Purpose
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)

Condition Intervention
Benign Prostatic Hyperplasia Drug: Doxazosin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Expression of alpha-1 adrenoceptor [ Time Frame: before treatment and 12mos and 24 mos after treatment ]

Secondary Outcome Measures:
  • International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events [ Time Frame: before treatment and 3mos, 12mos, and 24mos after treatment ]

Enrollment: 25
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxazosin 4mg
doxazosin 4mg group
Drug: Doxazosin
Treatment with doxazosin 4mg daily for 24 mos
Other Name: Cadura XL 4mg
Experimental: doxazosin 8mg
doxazosin 8mg group
Drug: Doxazosin
Treatment with doxazosin 8mg daily for 24 mos
Other Name: Cadura XL 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730418


Locations
Korea, Republic of
Samsung Medical Center
SEoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kru-Sung Lee, Ph.D., M.D. Samsung Medical Center
  More Information

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00730418     History of Changes
Other Study ID Numbers: 2006-08-118
First Submitted: August 7, 2008
First Posted: August 8, 2008
Last Update Posted: August 26, 2010
Last Verified: August 2010

Keywords provided by Samsung Medical Center:
Benign Prostatic Hyperplasia
alpha Adrenergic Blockers
alpha-1 Adrenergic Receptor

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Adrenergic Agents
Doxazosin
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists