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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH); Enlarged Prostate
• Interventions: Drug: finasteride; Drug: 2.5 mg NX-1207; Drug: 0.125 mg NX-1207

• Registration Number: NCT00759135
• Lead Sponsor: Nymox Corporation

Brief Summary

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

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

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-01
• Study Completion: 2008-05
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Disposition First Submitted: 2010-08-30
• Disposition First Submitted QC: 2010-08-30
• Disposition First Posted: 2010-09-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 85

Inclusion Criteria

1. Documented history of BPH for at least 1 year
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax < 15 mL/sec

Exclusion Criteria

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Surgery or MIST in the previous 12 months for treatment of BPH
5. Post-void residual urine volume > 350 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	finasteride	5.0 mg finasteride q.d.
1	2.5 mg NX-1207	Single therapeutic dose of 2.5 mg NX-1207
2	0.125 mg NX-1207	Single low dose of 0.125 mg NX-1207 for dose-response evaluation

Primary Outcome Measures

Name	Time	Method
Change in BPH Symptom Score (AUA SI)	90 days

Secondary Outcome Measures

Name	Time	Method
Change in Prostate Volume	90 days
Change in Qmax	90 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

Trial Locations

Locations (1)

Nymox Investigational Site; 🇺🇸 San Antonio, Texas, United States