Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
NCT01846793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2017-03-10
Summary
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
Conditions
- Benign Prostatic Hyperplasia
- BPH
- Lower Urinary Tract Symptoms (LUTS)
- LUTS
Interventions
- DRUG
-
NX-1207
2.5 mg NX-1207 in 10 mL saline vehicle
Sponsors & Collaborators
-
Nymox Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- United States
Study Locations
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