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

Tracking Information
First Received Date ^ICMJE	April 13, 2009
Last Updated Date	April 13, 2009
Start Date ^ICMJE	January 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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 HIF-1 and VEGF in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Benign Prostatic Hyperplasia
Intervention ^ICMJE	Drug: dutasteride 5mg, oral, daily
Study Arm (s)	Active Comparator: 1 dutasteride Intervention: Drug: dutasteride No Intervention: 2 control
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
Enrollment ^ICMJE	40
Completion Date	Not Provided
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 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
Gender	Male
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00880672
Other Study ID Numbers ^ICMJE	JHKu1
Has Data Monitoring Committee	Yes
Responsible Party	Jae-Seung Paick/Professor, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Korean Urological Association GSK, Korea
Investigators ^ICMJE	Not Provided
Information Provided By	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

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