Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
Conditions
Keywords
Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
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.
Interventions
DRUG2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
DRUG0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
DRUGfinasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Sponsors
Nymox Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BPH Symptom Score (AUA SI) | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Change in Prostate Volume | 90 days |
| Change in Qmax | 90 days |
| Change in BPH Symptom Score (AUA SI) | 30 days |
| Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug | 180 days |
Countries
United States
Outcome results
None listed