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

Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01438775

Enrollment

192

Registered

2011-09-22

Start date

2011-09-30

Completion date

2013-01-31

Last updated

2014-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms, LUTS, LUTS secondary to BPH, LUTS/BPH, Benign prostatic obstruction, BPO, Bladder outlet obstruction, BOO

Brief summary

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.

Interventions

DRUGNX-1207

2.5 mg NX-1207 in 10 mL saline vehicle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	180 days	Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).

Secondary

Measure	Time frame	Description
Symptomatic Improvement	90 days	Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
Prostate Volume Change	90 days	Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Change in Urinary Peak Flow	90 days	Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026