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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:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00759135
First received: September 23, 2008
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

Drug Information available for: Finasteride
U.S. FDA Resources

Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Prostate Volume [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in Qmax [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   45 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759135

  Show 30 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00759135     History of Changes
Other Study ID Numbers: NX02-0016
Study First Received: September 23, 2008
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013