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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00431626 |
Purpose
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hyperplasia |
Drug: Dutasteride (Avodart) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Kevin T. McVary, MD | Northwestern University |
More Information
| Study ID Numbers: | 0348-040 |
| Study First Received: | February 2, 2007 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00431626 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Benign Prostatic Hyperplasia Lower Urinary |
Track Symptoms Laser Transurethral Prostate |
|
Dutasteride Hyperplasia Pathologic Processes Molecular Mechanisms of Pharmacological Action Prostatic Diseases |
Prostatic Hyperplasia Enzyme Inhibitors Genital Diseases, Male Pharmacologic Actions |