Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT01454349

Run by

Sophiris Bio Corp

People needed

40

Starts

2011-09-01

Expected to finish

2013-08-01

Last updated by the study team

2013-08-21

Who can join

Age: 50 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Orange County Medical Research Center — Laguna Hills, California, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• California Professional Research — Newport Beach, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• South Florida Medical Research — Aventura, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• The Iowa Clinic — West Des Moines, Iowa, United States
• Accumed Research Associates — Garden City, New York, United States
• University Urology Associates — New York, New York, United States
• Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States
• TriState Urological Services — Cincinnatti, Ohio, United States
• Urologic Consultants of SE Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Research Across America — Carrollton, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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