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

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

DOUBLE

Enrollment

500

Conditions

Benign Prostatic Hyperplasia

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. IPSS ≥ 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 (41)

Outcomes

Primary Outcomes

International Prostate Symptom Score (IPSS)

Time frame: 365 days

Secondary Outcomes

International Prostate Symptom Score (IPSS)

Time frame: 90 days

International Prostate Symptom Score (IPSS)

Time frame: 180 days

International Prostate Symptom Score (IPSS)

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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For information concerning this clinical site, please contact Nymox at 800-936-9669

Birmingham, Alabama, United States