Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
NCT ID: NCT00759135
Last Updated: 2012-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2007-05-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
NCT00945490
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
NCT00918983
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
NCT01846793
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
NCT01438775
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
NCT02003742
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Single therapeutic dose of 2.5 mg NX-1207
2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
2
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
3
5.0 mg finasteride q.d.
finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec
Exclusion Criteria
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
45 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nymox Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Nymox Investigational Site
Sarasota, Florida, United States
Nymox Investigational Site
Greenwood, Indiana, United States
Nymox Investigational Site
Jeffersonville, Indiana, United States
Nymox Investigational Site
Shreveport, Louisiana, United States
Nymox Investigational Site
Missoula, Montana, United States
Nymox Investigational Site
Las Vegas, Nevada, United States
Nymox Investigational Site
Lawrenceville, New Jersey, United States
Nymox Investigational Site
Marlton, New Jersey, United States
Nymox Investigational Site
Voorhees Township, New Jersey, United States
Nymox Investigational Site
Garden City, New York, United States
Nymox Investigational Site
Poughkeepsie, New York, United States
Nymox Investigational Site
Staten Island, New York, United States
Nymox Investigational Site
Lancaster, Pennsylvania, United States
Nymox Investigational Site
Myrtle Beach, South Carolina, United States
Nymox Investigational Site
Germantown, Tennessee, United States
Nymox Investigational Site
Arlington, Texas, United States
Nymox Investigational Site
Brownsville, Texas, United States
Nymox Investigational Site
Dallas, Texas, United States
Nymox Investigational Site
McAllen, Texas, United States
Nymox Investigational Site
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NX02-0016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.