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...
Date First Received: June 3, 2008
Last Updated: June 4, 2008
Verified by: Urologic Consultants of Southeastern PA, June 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2008
Overall Status: Enrolling by invitation
Estimated Enrollment: 50
Brief Summary
Official Title: “Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment
Study Primary Completion Date: July 2009
Intervention(s) in this Clinical Trial
- Drug: Dutasteride
- 0.5mg capsule, taken once daily for 12 months
Outcome Measures for this Clinical Trial
Primary Measures
- Laboratory parameters: including serum testosterone, DHT level and PSA
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Secondary Measures
- volume measurements of TRUSP and PVR
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
- A decrease in the AUASI
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Urologic Consultants of Southeastern PA
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690950
Study ID Number: 110895
ClinicalTrials.gov Identifier: NCT00690950
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
