Back to resultsA Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Primary Purpose
Benign Prostatic Hyperplasia
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dutasteride
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH
Eligibility Criteria
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
Sites / Locations
- Urologic Consultants of Southeastern PA
Outcomes
Primary Outcome Measures
Laboratory parameters: including serum testosterone, DHT level and PSA
Secondary Outcome Measures
volume measurements of TRUSP and PVR
A decrease in the AUASI
Full Information
NCT ID
NCT00690950
First Posted
June 3, 2008
Last Updated
June 4, 2008
Sponsor
Urologic Consultants of Southeastern PA
1. Study Identification
Unique Protocol Identification Number
NCT00690950
Brief Title
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Official Title
Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Urologic Consultants of Southeastern PA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
BPH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Intervention Description
0.5mg capsule, taken once daily for 12 months
Primary Outcome Measure Information:
Title
Laboratory parameters: including serum testosterone, DHT level and PSA
Time Frame
12 months
Secondary Outcome Measure Information:
Title
volume measurements of TRUSP and PVR
Time Frame
12 months
Title
A decrease in the AUASI
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Urologic Consultants of Southeastern PA
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.urologicconsultsepa.com
Description
Related Info
Learn more about this trial
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
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