A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Urologic Consultants of Southeastern PA

ClinicalTrials.gov Identifier:

NCT00690950

First received: June 3, 2008

Last updated: June 4, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 3, 2008
Last Updated Date	June 4, 2008
Start Date ^ICMJE	May 2008
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 4, 2008)	Laboratory parameters: including serum testosterone, DHT level and PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00690950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 4, 2008)	volume measurements of TRUSP and PVR [ Time Frame: 12 months ] [ Designated as safety issue: No ] A decrease in the AUASI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Official Title ^ICMJE	Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
Brief Summary	Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Benign Prostatic Hyperplasia
Intervention ^ICMJE	Drug: Dutasteride 0.5mg capsule, taken once daily for 12 months
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male Age 50-80 On finasteride for no less than 12 months Willing to undergo all necessary test in the 12 month evaluation Exclusion Criteria: History of medication non-compliance Unwillingness to undergo/tolerate 2 blood draws Unwillingness to tolerate/undergo 2 TRUSP
Gender	Male
Ages	50 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00690950
Other Study ID Numbers ^ICMJE	110895
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Richard C. Harkaway, Urologic consultants of Southeastern PA
Study Sponsor ^ICMJE	Urologic Consultants of Southeastern PA
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Urologic Consultants of Southeastern PA
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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