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

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ClinicalTrials.gov Identifier: NCT00600691
Recruitment Status : Terminated (Did not achieve enrollment goal and decided to terminate early)
First Posted : January 25, 2008
Last Update Posted : January 31, 2014
Health Canada
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Hematuria Hematospermia Drug: Finasteride Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy
Study Start Date : March 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Finasteride
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
5mg finasteride orally, daily for 2 weeks prior to prostate biopsy and one week following prostate biopsy.
Drug: Finasteride
one tablet (5mg) of finasteride

Primary Outcome Measures :
  1. Differences in rate and severity of hematuria and hematospermia among subjects in treatment and placebo groups. [ Time Frame: 2 & 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600691

Canada, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Health Canada
Merck Frosst Canada Ltd.
Principal Investigator: Peter Pommerville, MD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00600691     History of Changes
Other Study ID Numbers: H07-01188
Health Canada Control #118638
Merck Frosst #IISP #P2587
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

Keywords provided by University of British Columbia:
prostate biopsy

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Pathologic Processes
Genital Diseases, Male
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents