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Trial record 31 of 118 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00880672
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : June 12, 2013
Sponsor:
Collaborators:
The Korean Urological Association
GlaxoSmithKline
Information provided by (Responsible Party):
Ja Hyeon Ku,, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2009
First Posted Date  ICMJE April 14, 2009
Last Update Posted Date June 12, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
HIF-1a and VEGF expression [ Time Frame: 2 weeks ]
effects of dutasteride on the expression of angiogenesis markers in rat and human prostates
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00880672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
Official Title  ICMJE Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
Brief Summary The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).
Detailed Description A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE Drug: dutasteride
5mg, oral, daily, 2-4 weeks
Study Arms  ICMJE
  • Active Comparator: dutasteride
    oral, 5mg, once per day, 2 weeks
    Intervention: Drug: dutasteride
  • Placebo Comparator: placebo
    oral, 5mg, once per day, 2 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • informed consent
  • 50 years old or older
  • International Prostate Symptom Score (IPSS) >8
  • Maximum flow rate (Qmax) <15 ml/s
  • transurethral resection of the prostate (TURP)

Exclusion Criteria:

  • urethral catheter
  • urinary tract infection (UTI)
  • liver disease
  • renal disease
  • unexplained hematuria
  • prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative)
  • interstitial cystitis
  • bladder cancer or prostate cancer
  • pelvic surgery or irradiation
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00880672
Other Study ID Numbers  ICMJE JHKu1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ja Hyeon Ku,, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • The Korean Urological Association
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Jae-Seung paick, MD, PhD Dept. of Urology, Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP