NCT00759135

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Nymox Corporation · Industry
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Benign Prostatic Hyperplasia (BPH)
• Enlarged Prostate

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-01-01
• Completion: 2008-05-01
• First posted: 2008-09-25
• Last updated: 2012-06-14

Locations

30 sites across 1 country: United States