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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759135
First Posted: September 25, 2008
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nymox Corporation
  Purpose
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.

Condition Intervention Phase
Benign Prostatic Hyperplasia (BPH) Enlarged Prostate Drug: 2.5 mg NX-1207 Drug: 0.125 mg NX-1207 Drug: finasteride Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 85
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single therapeutic dose of 2.5 mg NX-1207
Drug: 2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
Experimental: 2
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
Drug: 0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
Active Comparator: 3
5.0 mg finasteride q.d.
Drug: finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759135


  Show 30 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00759135     History of Changes
Other Study ID Numbers: NX02-0016
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Nymox Corporation:
Benign Prostatic Hyperplasia
BPH
Enlarged Prostate

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents