Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Official Title
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Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH

Conditions
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Benign Prostatic Hyperplasia (BPH), Enlarged Prostate

Intervention / Treatment
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* Drug: 2.5 mg NX-1207
* Drug: 0.125 mg NX-1207
* Drug: finasteride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single therapeutic dose of 2.5 mg NX-1207 | Drug: 2.5 mg NX-1207<br>* Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207<br>|
| Experimental: 2<br>Single low dose of 0.125 mg NX-1207 for dose-response evaluation | Drug: 0.125 mg NX-1207<br>* Low dose; single intraprostatic injection of 0.125 mg NX-1207<br>|
| Active Comparator: 3<br>5.0 mg finasteride q.d. | Drug: finasteride<br>* Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BPH Symptom Score (AUA SI) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prostate Volume |  | 90 days | 
| Change in Qmax |  | 90 days | 
| Change in BPH Symptom Score (AUA SI) |  | 30 days | 
| Change in BPH Symptom Score (AUA SI) |  | 180 days | 
| Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, BPH, Enlarged Prostate