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

Primary Purpose

Benign Prostatic Hyperplasia (BPH), Enlarged Prostate

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2.5 mg NX-1207
0.125 mg NX-1207
finasteride
Sponsored by
Nymox Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site
  • Nymox Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Single therapeutic dose of 2.5 mg NX-1207

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

5.0 mg finasteride q.d.

Outcomes

Primary Outcome Measures

Change in BPH Symptom Score (AUA SI)

Secondary Outcome Measures

Change in Prostate Volume
Change in Qmax
Change in BPH Symptom Score (AUA SI)
Change in BPH Symptom Score (AUA SI)
Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug

Full Information

First Posted
September 23, 2008
Last Updated
June 12, 2012
Sponsor
Nymox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00759135
Brief Title
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
Official Title
Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nymox Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
Keywords
Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Single therapeutic dose of 2.5 mg NX-1207
Arm Title
2
Arm Type
Experimental
Arm Description
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
Arm Title
3
Arm Type
Active Comparator
Arm Description
5.0 mg finasteride q.d.
Intervention Type
Drug
Intervention Name(s)
2.5 mg NX-1207
Intervention Description
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
Intervention Type
Drug
Intervention Name(s)
0.125 mg NX-1207
Intervention Description
Low dose; single intraprostatic injection of 0.125 mg NX-1207
Intervention Type
Drug
Intervention Name(s)
finasteride
Intervention Description
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Primary Outcome Measure Information:
Title
Change in BPH Symptom Score (AUA SI)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in Prostate Volume
Time Frame
90 days
Title
Change in Qmax
Time Frame
90 days
Title
Change in BPH Symptom Score (AUA SI)
Time Frame
30 days
Title
Change in BPH Symptom Score (AUA SI)
Time Frame
180 days
Title
Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
Time Frame
180 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of BPH for at least 1 year AUA SI ≥ 15 Prostate Volume ≥ 30 mL ≤ 70 mL Qmax < 15 mL/sec Exclusion Criteria: 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
Facility Information:
Facility Name
Nymox Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Nymox Investigational Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Nymox Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Nymox Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Nymox Investigational Site
City
Atherton
State/Province
California
Country
United States
Facility Name
Nymox Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Nymox Investigational Site
City
Modesto
State/Province
California
Country
United States
Facility Name
Nymox Investigational Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Nymox Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Nymox Investigational Site
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Nymox Investigational Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Nymox Investigational Site
City
Greenwood
State/Province
Indiana
Country
United States
Facility Name
Nymox Investigational Site
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Nymox Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Nymox Investigational Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Nymox Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Nymox Investigational Site
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Nymox Investigational Site
City
Marlton
State/Province
New Jersey
Country
United States
Facility Name
Nymox Investigational Site
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Nymox Investigational Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Nymox Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Nymox Investigational Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Nymox Investigational Site
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
Nymox Investigational Site
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Nymox Investigational Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Nymox Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
Nymox Investigational Site
City
Brownsville
State/Province
Texas
Country
United States
Facility Name
Nymox Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Nymox Investigational Site
City
McAllen
State/Province
Texas
Country
United States
Facility Name
Nymox Investigational Site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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