Status:
COMPLETED
Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)
Lead Sponsor:
North Florida/South Georgia Veterans Health System
Conditions:
Benign Prostatic Hypertrophy
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
Detailed Description
STUDY SUMMARY TITLE: A Pilot Investigation of Dutasteride (Avodart) After Failure of Finasteride (Proscar) in the Management of Symptomatic Prostatic Enlargement/Hypertrophy OBJECTIVE: To determine t...
Eligibility Criteria
Inclusion
- Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS\> 10;Q-max \> 5cc/sec and \<10c/sec (total voided volume of at least 125cc); post void volumes \> 200cc)
- Prostate volume \> 30cc and \< 80cc by transrectal ultrasound measurement
- Total Serum PSA of \< 15 ng/ml (corrected for Finasteride therapy)
- Willingness and ability to give written informed consent and comply with study instructions and procedures.
Exclusion
- Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.
- Total serum corrected PSA of greater than 15 ng/ml
- History or clinical evidence of prostate cancer
- History of acute urinary retention in three months prior.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00382356
Start Date
November 1 2004
End Date
July 1 2009
Last Update
October 19 2012
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