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Completed

NCT Number: NCT00730418

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

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)

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxazosin

Drug

Treatment with doxazosin 4mg daily for 24 mos

Other names: Cadura XL 4mg

Primary outcomes

  1. Expression of alpha-1 adrenoceptor

    Time frame: before treatment and 12mos and 24 mos after treatment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2008
Registry last updated
Aug 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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