Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Nymox

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: NX-1207

Study type

Interventional

Funder types

Industry

Identifiers

NCT01438775

NX02-0020

Details and patient eligibility

About

This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.

Enrollment

192 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be male aged 45 or older.
Sign an informed consent form.
Be in good health.
Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
Have Prostate Gland Volume ≥ 25 mL (25 g).

Exclusion criteria

Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
Post-void residual urine volume > 200 mL
Presence of a symptomatic median lobe of the prostate
History of use of self-catheterization for urinary retention.
Urinary retention in the previous 12 months.
Prostatitis
Urinary tract infection more than once in the past 12 months
Prostate or bladder cancer.
PSA ≥10 ng/mL
Poorly controlled diabetes
History or evidence of illness or condition that may interfere with study or endanger subject
Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
Use of specific prescribed medications that may interfere with study or endanger subject