E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign Prostatic Hyperplasia (BPH) |
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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 collect safety and efficacy data for this dosage regimen of cetrorelix pamoate |
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E.2.2 | Secondary objectives of the trial | |
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 screening); 4. Uroflow (max) 5 -15 mL/sec
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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; 4. Clinical significant increase of bleeding time 5. 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), cancer (considered as not cured) except basal cell or squamous cell carcinoma of the skin 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 5α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of treatment-emergent AEs |
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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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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
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Last visit of the last patient |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |