Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Nymox Corporation192 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

Benign Prostatic Hyperplasia

Interventions

NX-1207DRUG

2.5 mg NX-1207 in 10 mL saline vehicle

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be male aged 45 or older. * Sign an informed consent form. * Be in good health. * Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit. * Have Prostate Gland Volume ≥ 25 mL (25 g). Exclusion Criteria: * Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection * Post-void residual urine volume \> 200 mL * Presence of a symptomatic median lobe of the prostate * History of use of self-catheterization for urinary retention. * Urinary retention in the previous 12 months. * Prostatitis * Urinary tract infection more than once in the past 12 months * Prostate or bladder cancer. * PSA ≥10 ng/mL * Poorly controlled diabetes * History or evidence of illness or condition that may interfere with study or endanger subject * Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days * Use of specific prescribed medications that may interfere with study or endanger subject

Locations (28)

Outcomes

Primary Outcomes

Safety

Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).

Time frame: 180 days

Secondary Outcomes

Symptomatic Improvement

Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).

Time frame: 90 days

Prostate Volume Change

Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography

Time frame: 90 days

Change in Urinary Peak Flow

Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).

Time frame: 90 days

Symptomatic Improvement

Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

Time frame: 180 days

Data from ClinicalTrials.gov

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