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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Doxazosin
Doxazosin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

doxazosin 4mg

doxazosin 8mg

Arm Description

doxazosin 4mg group

doxazosin 8mg group

Outcomes

Primary Outcome Measures

Expression of alpha-1 adrenoceptor

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

Full Information

First Posted
August 7, 2008
Last Updated
August 25, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00730418
Brief Title
Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
Official Title
A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
doxazosin 4mg
Arm Type
Experimental
Arm Description
doxazosin 4mg group
Arm Title
doxazosin 8mg
Arm Type
Experimental
Arm Description
doxazosin 8mg group
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Other Intervention Name(s)
Cadura XL 4mg
Intervention Description
Treatment with doxazosin 4mg daily for 24 mos
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Other Intervention Name(s)
Cadura XL 8mg
Intervention Description
Treatment with doxazosin 8mg daily for 24 mos
Primary Outcome Measure Information:
Title
Expression of alpha-1 adrenoceptor
Time Frame
before treatment and 12mos and 24 mos after treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kru-Sung Lee, Ph.D., M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
SEoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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