Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: a double-blind placebo-controlled efficacy study - ND
- Conditions
- Benign Prostatic HyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia
- Registration Number
- EUCTR2007-002598-30-IT
- Lead Sponsor
- AETERNA ZENTARIS GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 400
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 repeat bone mineral density assessment at Week 52 6. Normal BMD at baseline (T-score between -1 SD to +1 SD, based upon young normal males).
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
Safety concerns: 1. Urgent need for prostate surgery; 2. Serum PSA ≥ 10 ng/ml; a patient with serum PSA > 4 ng/ml (but < 10 ng/ml) is only eligible if prostate cancer has been excluded to the satisfaction of the investigator (e.g., by prostate biopsy). ; 3. History of allergic reactivity to peptide hormones; 4. Eczema (atopic dermatitis) treated during the last 6 months; 5. Clinical significant increase of bleeding time (e.g., caused by idiopathic bleeding disorders and chronic anticoagulation therapy) and any other clinical condition that may interfere with the administration of study medication by intramuscular injection (e.g., local infection, paresis, and paralysis at the site of injection); 6. Major organ dysfunction, e.g., insulin-dependent diabetes, recent myocardial infarction (within 6 months of enrolment), history of unstable angina or newly diagnosed angina pectoris, current congestive heart failure, uncontrolled hypertension, current serious arrhythmia, use of concomitant Class 1A or Class III antiarrhythmic medications, personal or family history of long QT syndrome, clinically relevant ECG abnormalities (including QT/QTc interval > 450 ms) or clinically relevant chronic or acute infections; Lack of suitability for the trial: 7. Prior surgical treatment of the prostate or bladder; 8. Current or recent treatment with sexual hormone drugs or 5α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to randomization at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to randomization at Week 0 (see list of drugs in section 6.3.1); 9. Newly started treatment with tricyclic antidepressants, cholestyramine, disopyramide, ketoconazole, and anticholinergics drugs (see list of drugs in section 6.3.1). An ongoing treatment at a stable dosage during the entire study is acceptable; 10. Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy; 11. History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months; 12. Residual urine volume of > 350 mL; 13. Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the patient?s proper compliance; Administrative reasons: 14. Lack of ability or willingness to give written informed consent; 15. Anticipated non-availability for study visits/procedures. For a patient considered for baseline bone mineral density assessment at Screening: 16. History of osteoporosis with or without fracture, osteopenia, alcoholism, hyperparathyroidism, hypoparathyroidism or hyperthyroidism. 17. 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]. 18. 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signes and syntoms;Secondary Objective: Determination of change in bone mass in a subgroup of patients;Primary end point(s): Absolute change in IPSS between baseline (Week -2) and Week 52
- Secondary Outcome Measures
Name Time Method