E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign Prostatic Hyperplasia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004446 |
E.1.2 | Term | Benign prostatic hyperplasia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signes and syntoms |
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E.2.2 | Secondary objectives of the trial |
Determination of change in bone mass in a subgroup of patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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). |
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E.4 | Principal exclusion criteria |
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 patients 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change in IPSS between baseline (Week -2) and Week 52 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Ultima visita dell'ultimo paziente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |