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Completed

NCT Number: NCT00945490

Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

For information concerning this clinical site, please contact Nymox at 800-936-9669., Laguna Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed informed consent prior to enrolment in the study
  • AUASI ≥ 15
  • Prostate Volume ≥ 30 mL ≤ 70 mL
  • Qmax < 15 mL/sec based on a minimum void of 125 mL
  • Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

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
  • Previous surgery or MIST for treatment of BPH
  • Post-void residual urine volume > 200 mL
  • PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
  • Participation in a study of any investigational drug or device within the previous 90 days
  • Prostate cancer

Treatment and study plan

NX-1207

Drug

Single intraprostatic injection of 2.5 mg NX-1207

Placebo

Drug

Single intraprostatic injection of placebo

Primary outcomes

  1. American Urological Association Symptom Index (AUASI)

    Time frame: 365 days

Secondary outcomes

  1. American Urological Association Symptom Index (AUASI)

    Time frame: 90 days

  2. American Urological Association Symptom Index (AUASI)

    Time frame: 180 days

  3. American Urological Association Symptom Index (AUASI)

    Time frame: 270 days

  4. Peak urine flow rate (Qmax)

    Time frame: 365 days

  5. Peak urine flow rate (Qmax)

    Time frame: 90 days

  6. Peak urine flow rate (Qmax)

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Nymox Corporation

Industry

Registry information

Official study title

Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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