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Completed

NCT Number: NCT00759135

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

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.

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Key information

Conditions

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

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Nymox Investigational Site, Huntsville, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

2.5 mg NX-1207

Drug

Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207

0.125 mg NX-1207

Drug

Low dose; single intraprostatic injection of 0.125 mg NX-1207

finasteride

Drug

Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Primary outcomes

  1. Change in BPH Symptom Score (AUA SI)

    Time frame: 90 days

Secondary outcomes

  1. Change in Prostate Volume

    Time frame: 90 days

  2. Change in Qmax

    Time frame: 90 days

  3. Change in BPH Symptom Score (AUA SI)

    Time frame: 30 days

  4. Change in BPH Symptom Score (AUA SI)

    Time frame: 180 days

  5. Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Nymox Corporation

Industry

Registry information

Official study title

Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 25, 2008
Registry last updated
Jun 14, 2012

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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