Trials / Completed
CompletedNCT01966614
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 479 (actual)
- Sponsor
- Sophiris Bio Corp · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRX302 | Single intraprostatic bilateral injection at a dose of 0.6 µg/g |
| OTHER | Placebo | Single intraprostatic bilateral injection of vehicle only |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-10-21
- Last updated
- 2017-04-27
Locations
76 sites across 6 countries: United States, Australia, Canada, New Zealand, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01966614. Inclusion in this directory is not an endorsement.