Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Benign prostatic hyperplasia, BPH, Enlarged prostate
Brief summary
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
Interventions
DRUGNX-1207
Single intraprostatic injection of 2.5 mg NX-1207
DRUGPlacebo
Single intraprostatic injection of placebo
Sponsors
Nymox Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide signed informed consent prior to enrolment in the study 2. AUASI ≥ 15 3. Prostate Volume ≥ 30 mL ≤ 70 mL 4. Qmax \< 15 mL/sec based on a minimum void of 125 mL 5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
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. Previous surgery or MIST for treatment of BPH 5. Post-void residual urine volume \> 200 mL 6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL 7. Participation in a study of any investigational drug or device within the previous 90 days 8. Prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Urological Association Symptom Index (AUASI) | 365 days |
Secondary
| Measure | Time frame |
|---|---|
| American Urological Association Symptom Index (AUASI) | 90 days |
| Peak urine flow rate (Qmax) | 365 days |
Countries
United States
Outcome results
None listed