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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00730418
First received: August 7, 2008
Last updated: August 25, 2010
Last verified: August 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00730418     History of Changes
Other Study ID Numbers: 2006-08-118
Study First Received: August 7, 2008
Last Updated: August 25, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on April 17, 2014