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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730418
• Other study ID #: 2006-08-118
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: August 25, 2010
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Doxazosin
Treatment with doxazosin 4mg daily for 24 mos
• Doxazosin
Treatment with doxazosin 8mg daily for 24 mos

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	SEoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of alpha-1 adrenoceptor		before treatment and 12mos and 24 mos after treatment	No
Secondary	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	Yes