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

NCT00759135 | Completed Phase 2

• 1 other identifier: NX02-0016
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia (BPH); Enlarged Prostate

Keywords

Benign Prostatic Hyperplasia; BPH; Enlarged Prostate

Outcome Measures

Primary Outcomes (1)

• Change in BPH Symptom Score (AUA SI)

  90 days

Secondary Outcomes (5)

• Change in Prostate Volume

  90 days

• Change in Qmax

  90 days

• Change in BPH Symptom Score (AUA SI)

  30 days

• Change in BPH Symptom Score (AUA SI)

  180 days

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

  180 days

Study Arms (3)

1

EXPERIMENTAL

Single therapeutic dose of 2.5 mg NX-1207

Drug: 2.5 mg NX-1207

2

EXPERIMENTAL

Single low dose of 0.125 mg NX-1207 for dose-response evaluation

Drug: 0.125 mg NX-1207

3

ACTIVE COMPARATOR

5.0 mg finasteride q.d.

Drug: finasteride

Interventions

2.5 mg NX-1207 DRUG

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

1

0.125 mg NX-1207 DRUG

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

2

finasteride DRUG

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

3

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of BPH for at least 1 year
• AUA SI ≥ 15
• Prostate Volume ≥ 30 mL ≤ 70 mL
• Qmax \< 15 mL/sec

You may not qualify if:

• History of illness or condition that may interfere with study or endanger subject
• Use of prescribed medications that may interfere with study or endanger subject
• Presence of a median lobe of the prostate
• Surgery or MIST in the previous 12 months for treatment of BPH
• Post-void residual urine volume \> 350 mL
• PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Sponsors & Collaborators

• Nymox Corporation: lead

Study Sites (30)

Nymox Investigational Site

Huntsville, Alabama, United States

Location

Nymox Investigational Site

Tucson, Arizona, United States

Location

Nymox Investigational Site

Little Rock, Arkansas, United States

Location

Nymox Investigational Site

Anaheim, California, United States

Location

Nymox Investigational Site

Atherton, California, United States

Location

Nymox Investigational Site

Long Beach, California, United States

Location

Nymox Investigational Site

Modesto, California, United States

Location

Nymox Investigational Site

Newport Beach, California, United States

Location

Nymox Investigational Site

Denver, Colorado, United States

Location

Nymox Investigational Site

New Britain, Connecticut, United States

Location

Nymox Investigational Site

Sarasota, Florida, United States

Location

Nymox Investigational Site

Greenwood, Indiana, United States

Location

Nymox Investigational Site

Jeffersonville, Indiana, United States

Location

Nymox Investigational Site

Shreveport, Louisiana, United States

Location

Nymox Investigational Site

Missoula, Montana, United States

Location

Nymox Investigational Site

Las Vegas, Nevada, United States

Location

Nymox Investigational Site

Lawrenceville, New Jersey, United States

Location

Nymox Investigational Site

Marlton, New Jersey, United States

Location

Nymox Investigational Site

Voorhees Township, New Jersey, United States

Location

Nymox Investigational Site

Garden City, New York, United States

Location

Nymox Investigational Site

Poughkeepsie, New York, United States

Location

Nymox Investigational Site

Staten Island, New York, United States

Location

Nymox Investigational Site

Lancaster, Pennsylvania, United States

Location

Nymox Investigational Site

Myrtle Beach, South Carolina, United States

Location

Nymox Investigational Site

Germantown, Tennessee, United States

Location

Nymox Investigational Site

Arlington, Texas, United States

Location

Nymox Investigational Site

Brownsville, Texas, United States

Location

Nymox Investigational Site

Dallas, Texas, United States

Location

Nymox Investigational Site

McAllen, Texas, United States

Location

Nymox Investigational Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

fexapotide; Finasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (30)