NCT00759135CompletedPhase 2
Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Nymox Corporation
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Change in BPH Symptom Score (AUA SI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Single therapeutic dose of 2.5 mg NX-1207
Intervention: 2.5 mg NX-1207 (Drug)
2
Experimental
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
Intervention: 0.125 mg NX-1207 (Drug)
3
Active Comparator
5.0 mg finasteride q.d.
Intervention: finasteride (Drug)
Outcomes
Primary Outcomes
Change in BPH Symptom Score (AUA SI)
Time Frame: 90 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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