Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of The Prostate
Information source: Merck
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: finasteride (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic
hyperplasia (BPH). a common complication of TURP is blood loss. preliminary data suggest that
preoperative finasteride, a 5a-reductase inhibitor, may reduce blood loss during TURP.
however, no study has examined the effect of preoperative finasteride on clinical outcomes.
Clinical Details
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of The Prostate
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
TRUS-confirmed prostate gland greater than 30g
18 years of age or older
Fit and scheduled to receive TURP
Approval of the treating urologist
Able to understand and provide written informed consent in english
Exclusion Criteria:
No active psychiatric condition
No previous finasteride use
Normal dre
PSA less than or equal to 4. 0 ng/ml
No current anticoagulation use (heparin, warfarin)
No esrd
No previous prostate or urethral surgery
Locations and Contacts
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Francois Bertrand, Dr., Phone: 1-514-428-2641
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: December 2007
Ending date: December 2009
Last updated: December 24, 2007
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