Benign Prostatic Hyperplasia (PBH) MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Sponsors
Aeterna Zentaris GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Benign Prostatic Hyperplasia, based on medical history 2. Voiding symptoms: IPSS = 13 3. 50 years or older (at time of randomization) 4. Complete Week 52 visit to be eligible to the open-label phase 5. Uroflow (max) 5 - 15 mL/sec. For patients undergoing the bone mineral density assessment: 6. Normal BMD at baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Safety concerns: 1. Urgent need for prostate surgery 2. Serum PSA = 10 ng/ml (if PSA > 4 and 450 ms) or clinically relevant chronic or acute infections; Lack of suitability for the trial: 6. Prior surgical treatment of the prostate or bladder; 7. Current or recent treatment with sexual hormone drugs or 5 a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to randomization at Week 0 or with a blockers or saw palmetto within the last 6 weeks prior to randomization at Week 0 8. Newly started treatment with tricyclic antidepressants, cholestyramine, disopyramide, ketoconazole, and anticholinergics drugs. 9. Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy 10. History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months; 11. Residual urine volume of > 350 mL; 12. Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the patient’s proper compliance. For patients undergoing the bone mineral density assessment: 13. History of osteoporosis with or without fracture, osteopenia, alcoholism, hyperparathyroidism, hypoparathyroidism or hyperthyroidism 14. Currently receiving or have received in the previous 12 months any medication that affects bone mineral density [including any treatment for osteoporosis, anticonvulsant therapy, chronic heparin treatment (> 3 months), systemic corticosteroids, methotrexate] 15. Presence of a condition that would interfere with an accurate DEXA scan interpretation (i.e. history of lumbar laminectomy, bilateral hip prosthesis, severe lumbar scoliosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms;Secondary Objective: Determination of change in in bone mass density in a subgroub of patients;Primary end point(s): Absolute change in IPSS between baseline (Week -1) and Week 52 | — |
Countries
Bulgaria, Germany
Outcome results
None listed