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Sponsors and Collaborators: |
University of British Columbia Health, Canada Merck Frosst Canada Ltd. |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00600691 |
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 |
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Hematuria Hematospermia |
Drug: Finasteride |
Phase II |
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 |
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 |
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1: Experimental
5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.
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Drug: Finasteride
one tablet (5mg) of finasteride
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nathan Hoag | 250-216-4455 | natman@interchange.ubc.ca |
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 |
Principal Investigator: | Peter Pommerville, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Peter Pommerville ) |
Study ID Numbers: | H07-01188, Health Canada Control #118638, Merck Frosst #IISP #P2587 |
Study First Received: | January 14, 2008 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00600691 |
Health Authority: | Canada: Health Canada |
Finasteride hematuria hematospermia prostate biopsy |
Finasteride Urologic Diseases Hematuria Urination Disorders |
Genital Diseases, Male Hemorrhage Hemospermia |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |