Trial | NCT00759135  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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.
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
Study Started
May 31
2007
Primary Completion
Jan 31
2008
Study Completion
May 31
2008
Last Update
Jun 14
2012
Estimate

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)

1 Experimental

Single therapeutic dose of 2.5 mg NX-1207

2 Experimental

Single low dose of 0.125 mg NX-1207 for dose-response evaluation

3 Active Comparator

5.0 mg finasteride q.d.

Criteria 

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
No Results Posted