Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

Nymox Corporation500 enrolled

Overview

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

500

Conditions

Benign Prostatic Hyperplasia (BPH)

Interventions

NX-1207DRUG

Single intraprostatic injection of 2.5 mg NX-1207

PlaceboDRUG

Single intraprostatic injection of placebo

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provide signed informed consent prior to enrolment in the study 2. AUASI ≥ 15 3. Prostate Volume ≥ 30 mL ≤ 70 mL 4. Qmax \< 15 mL/sec based on a minimum void of 125 mL 5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study Exclusion Criteria: 1. History of illness or condition that may interfere with study or endanger subject 2. Use of prescribed medications that may interfere with study or endanger subject 3. Presence of a median lobe of the prostate 4. Previous surgery or MIST for treatment of BPH 5. Post-void residual urine volume \> 200 mL 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL 7. Participation in a study of any investigational drug or device within the previous 90 days 8. Prostate cancer

Locations (35)

Outcomes

Primary Outcomes

American Urological Association Symptom Index (AUASI)

Time frame: 365 days

Secondary Outcomes

American Urological Association Symptom Index (AUASI)

Time frame: 90 days

American Urological Association Symptom Index (AUASI)

Time frame: 180 days

American Urological Association Symptom Index (AUASI)

Time frame: 270 days

Peak urine flow rate (Qmax)

Time frame: 365 days

Peak urine flow rate (Qmax)

Time frame: 90 days

Peak urine flow rate (Qmax)

Time frame: 180 days

Data from ClinicalTrials.gov

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