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Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

This study has been completed.
Sponsor:
Collaborators:
Korean Urological Association
GSK, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00880672
First received: April 13, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as HIF-1 and VEGF in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).


Condition Intervention Phase
Benign Prostatic Hyperplasia
 Drug: dutasteride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Apoptosis and Expression of Neovascularization-Related Factors in Human Prostate Tissue After Administration of Dutasteride

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Enrollment: 40
Study Start Date: January 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 dutasteride Drug: dutasteride
5mg, oral, daily
No Intervention: 2 control

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent
  • 50 years old or older
  • IPSS >8
  • Qmax <15 ml/s
  • TURP

Exclusion Criteria:

  • urethral catheter
  • UTI
  • liver disease
  • renal disease
  • unexplained hematuria
  • PSA > 4ng/ml (included if prostate biopsy was negative)
  • interstitial cystitis
  • bladder cancer or prostate cancer
  • pelvic surgery or irradiation
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jae-Seung Paick/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00880672     History of Changes
Other Study ID Numbers: JHKu1
Study First Received: April 13, 2009
Last Updated: April 13, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
prostate, dutasteride, VEGF, HIF

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013