Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Nymox Corporation85 enrolled

Overview

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Benign Prostatic Hyperplasia (BPH)Enlarged Prostate

Interventions

2.5 mg NX-1207DRUG

Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207

0.125 mg NX-1207DRUG

Low dose; single intraprostatic injection of 0.125 mg NX-1207

finasterideDRUG

Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Eligibility

Sex: MALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Documented history of BPH for at least 1 year 2. AUA SI ≥ 15 3. Prostate Volume ≥ 30 mL ≤ 70 mL 4. Qmax \< 15 mL/sec 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. Surgery or MIST in the previous 12 months for treatment of BPH 5. Post-void residual urine volume \> 350 mL 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Locations (30)

Outcomes

Primary Outcomes

Change in BPH Symptom Score (AUA SI)

Time frame: 90 days

Secondary Outcomes

Change in Prostate Volume

Time frame: 90 days

Change in Qmax

Time frame: 90 days

Change in BPH Symptom Score (AUA SI)

Time frame: 30 days

Change in BPH Symptom Score (AUA SI)

Time frame: 180 days

Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug

Time frame: 180 days

Data from ClinicalTrials.gov

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Nymox Investigational Site

Huntsville, Alabama, United States

Nymox Investigational Site

Tucson, Arizona, United States

Nymox Investigational Site

Little Rock, Arkansas, United States

Nymox Investigational Site

Anaheim, California, United States

Nymox Investigational Site

Atherton, California, United States

Nymox Investigational Site

Long Beach, California, United States

Nymox Investigational Site

Modesto, California, United States

Nymox Investigational Site

Newport Beach, California, United States

Nymox Investigational Site

Denver, Colorado, United States

Nymox Investigational Site

New Britain, Connecticut, United States

...and 20 more locations