E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who have advanced carcinoma of the prostate suitable for hormonal manipulation |
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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 | 10060862 |
E.1.2 | Term | Prostate cancer |
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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 |
The aim of the study is to demonstrate that the Novosis Leuprorelin 3.57 mg implant is non-inferior to the reference product Enantone® Monats-Depot. Enantone® Monats-Depot has been chosen as the reference product as this is the originator product. |
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E.2.2 | Secondary objectives of the trial |
Percentage of patients who have reached castration level of testosterone (2 nmol/l) at the end of the study (Day 56). The plasma levels of leuprorelin and LH/FSH (Days 0, 7, 14, 21, 28, 35, 42, 49, 56) Number of non-responders The results of the clinical examination of the prostate
Description of Adverse Events/Serious Adverse Events Assessment of tolerability
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males aged 18 years or older Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention Life expectancy of at least six months The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form The patient is able to understand and follow instructions and is able to participate in the study for the entire period Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
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E.4 | Principal exclusion criteria |
Hypersensitivity to Enantone® or to other GnRH analogues Treatment with a drug modifying testosterone level or function is prohibited. To these belong e.g. flutamide, spironolactone, domperidone, cimetidine, amitriptyline, methyldopa, minoxidil, and finasteride Treatment and/or pretreatment with other GnRH analogues Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion Cancer disease within the last 10 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator Mental incapacity or language barriers precluding adequate understanding or co-operation Patients who have received an investigational drug within the last 12 weeks preceding Visit 1 Previous participation in this study Simultaneous or less than 30 days earlier participation in another clinical trial Known allergy against one of the ingredients in the test and reference preparation.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the AUC of the testosterone levels on Days 28, 35, 42, 49, and 56. The non-inferiority limit is stipulated as 80 % of the AUC of the reference product. If the two-sided 95 % confidence interval of the treatment effect lies completely above the non-inferiority margin, non-inferiority will be concluded |
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |