CompletedPhase 3

Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

United States160 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (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). 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. * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety

Timeframe: 180 days

Trial details

NCT IDNCT01846793

SponsorNymox Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials