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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2013

Geographic Reach

1 country

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

April 1, 2013

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed

Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

May 1, 2013

Last Update Submit

March 9, 2017

Conditions

Benign Prostatic Hyperplasia BPH Lower Urinary Tract Symptoms (LUTS)LUTS

Keywords

Benign prostatic hyperplasiaBPHLower urinary tract symptomsLUTSLUTS secondary to BPHLUTS/BPHBenign prostatic obstruction (BPO)BPOBladder outlet obstructionBOO

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Symptomatic Improvement
90 days
Prostate Volume Change
90 days
Change in Urinary Peak Flow
90 days.
Symptomatic Improvement
180 days

Study Arms (1)

Open Label Injection of NX-1207

EXPERIMENTAL

Intraprostatic injection of 2.5 mg NX-1207

Drug: NX-1207

Interventions

NX-1207DRUG

2.5 mg NX-1207 in 10 mL saline vehicle

Open Label Injection of NX-1207

Eligibility Criteria

Age45 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be male aged 45 or older.
Sign an informed consent form.
Be in good health.
Received NX-1207 in a previous completed study (other than NX02-0020) 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).

You may not qualify if:

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.
Prostate-Specific Antigen (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

Contact the study team to confirm eligibility.