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The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

This study is currently recruiting participants.
Verified by University of British Columbia, May 2008

Sponsors and Collaborators: University of British Columbia
Health, Canada
Merck Frosst Canada Ltd.
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00600691
  Purpose

The purpose of our study is primarily to evaluate the effects of 5mg finasteride on hematuria and hematospermia commonly associated with prostate biopsies. We hypothesize that 5mg of finasteride daily for two weeks preceding TRUS prostate biopsy and one week following will reduce hematuria and hematospermia commonly seen as complications following prostate biopsy. We also hypothesize that reducing complications will decrease concern among subjects and make for a more tolerable overall procedure than compared with subjects treated with placebo.


Condition Intervention Phase
Hematuria
Hematospermia
Drug: Finasteride
Phase II

ChemIDplus related topics:   Finasteride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups. [ Time Frame: 2 & 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences between placebo group and finasteride treatment group in: complication rates, overall subjective experience of biopsy procedure, and concern relating to biopsy. Monitor side effects between placebo and finasteride. [ Time Frame: 2 & 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   50
Study Start Date:   March 2008
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.
Drug: Finasteride
one tablet (5mg) of finasteride

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Written informed consent prior to the participation in any study related activity.
  2. Male subject already identified as requiring TRUS prostate biopsy for unrelated medical reasons.

Exclusion Criteria:

  1. Suspected or known liver disease.
  2. Suspected or known hematological disorders.
  3. Subjects who are candidates for immediate surgery.
  4. Known hypersensitivity to any component of the product.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600691

Contacts
Contact: Nathan Hoag     250-216-4455     natman@interchange.ubc.ca    

Locations
Canada, British Columbia
Royal Jubilee Hospital     Recruiting
      Victoria, British Columbia, Canada
      Contact: Nathan Hoag     250-216-4455     natman@interchange.ubc.ca    
Victoria General Hospital     Recruiting
      Victoria, British Columbia, Canada
      Contact: Nathan Hoag     250-216-4455     natman@interchange.ubc.ca    

Sponsors and Collaborators
University of British Columbia
Health, Canada
Merck Frosst Canada Ltd.

Investigators
Principal Investigator:     Peter Pommerville, MD     University of British Columbia    
  More Information

Responsible Party:   University of British Columbia ( Dr. Peter Pommerville )
Study ID Numbers:   H07-01188, Health Canada Control #118638, Merck Frosst #IISP #P2587
First Received:   January 14, 2008
Last Updated:   May 26, 2008
ClinicalTrials.gov Identifier:   NCT00600691
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
Finasteride  
hematuria  
hematospermia  
prostate biopsy  

Study placed in the following topic categories:
Finasteride
Urologic Diseases
Hematuria
Urination Disorders
Genital Diseases, Male
Hemorrhage
Hemospermia

Additional relevant MeSH terms:
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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