Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Benign Prostate Hyperplasia, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/28/2017 |
| Start Date: | October 2013 |
| End Date: | December 2015 |
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)
The purpose of this study is to evaluate the safety and efficacy of a single treatment of
PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Inclusion Criteria:
- Age ≥50 years
- Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
- IPSS ≥15
- Maximum urine flow (Qmax) of 5 - 15 mL/sec
- Prostate volume of 30 - 100 mL as determined by TRUS
- Serum prostate-specific antigen (PSA) values <10 ng/mL
- Post-void residual (PVR) <= 200 mL
Exclusion Criteria:
- Inability to void ≥125 mL urine
- Prior surgery/MIST for BPH
- 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
We found this trial at
48
sites
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