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

NCT00759135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2012-06-14

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostatic Hyperplasia (BPH)
  • Enlarged Prostate

Interventions

DRUG

2.5 mg NX-1207

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

DRUG

0.125 mg NX-1207

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

DRUG

finasteride

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

Sponsors & Collaborators

  • Nymox Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-01-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00759135 on ClinicalTrials.gov