Status:
COMPLETED
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Sophiris Bio Corp
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Eligibility Criteria
Inclusion
- Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
- Written informed consent prior to enrollment in the study
- IPSS ≥12
- Prostate volume of 30 - 100 mL as determined by TRUS
- Maximum urine flow (Qmax) of 4 - 15 mL/sec
- Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
- Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
- Blood PSA values \<10 ng/mL
Exclusion
- Inability to void at least 125 mL of urine
- PVR volume \>200 mL
- Presence of or history of certain conditions that could interfere with study results or endanger subject
- Use of certain prescribed medications that could interfere with study results
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01454349
Start Date
September 1 2011
End Date
August 1 2013
Last Update
August 21 2013
Active Locations (15)
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1
South Orange County Medical Research Center
Laguna Hills, California, United States, 92653
2
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
3
California Professional Research
Newport Beach, California, United States, 92660
4
University of Colorado Denver
Aurora, Colorado, United States, 80045