E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypogonadism and erectile dysfunction in patients with type 2 diabetes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
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 determine the effects of testosterone replacement therapy for hypogonadism on the thin layer of cells that line the veins and arteries and the dilation of these vessels and the subsequent availability of Nitric oxide (a chemical in the blood that improves blood flow), also inflammation of the cells in patients with Diabetes. |
|
E.2.2 | Secondary objectives of the trial |
To determine the effect of testosterone replacement therapy on parameters such as body mass index, waist circumference, glycaemic control( Hba1c), lipids and blood pressure. To determine the effects of testosterone on hypogonadal men with or without erectile dysfunction; a subgroup of patients will be treated with Levitra (vardenafil). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
i. Type 2 Diabetes as judged by WHO criteria:(i)onset of diabetes mellitus after the age of 30 years (ii) blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes and (iii)no history of diabetic ketoacidosis. ii. Symptomatic Hypogonadism as defined by: Total testosterone below 10mmol/l Aging males' symptom score (AMS)above 36 iii. Hypogonadic men with or without erectile dysfunction. 1v. Age range 50-80 years v. Patients naive to testosterone treatment |
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E.4 | Principal exclusion criteria |
i. Patients with uncontrolled hypertension (BP>145/95 on treatment)or significant hypotension. (BP<100 systolic) ii. Current smokers. iii. Recent myocardial infarction (<6 months), unstable angina or ongoing chest pain, recent (within 6 months) cardiac intervention (e.g. angioplasty, stenting or CABG) or stroke. iv. Patients with clinical nephropathy ( 24 hr protein>0.5g or dipstix protein+) or moderate renal failure ( serum creatinine> 150umol/l) v. History of prostate cancer or suspicion of prostate cancer on clinical examination. vi. Androgen dependent carcinoma of the male mammary gland. vii. Liver tumors. viii. Hypersensitivity to NEBIDO or Levitra or any of their incipients. ix. Polycythemia. x. General systemic illness, including cardiac, renal or hepatic insufficiency. xi. Patients on nitrates will not be included in the Levitra arm. xii. History of loss of vision in one eye because of non arteric ischaemic optic neuropathy(NAION), regardlesss of whether this episode was in connection or not with previous PDE5 inhibitor exposure. xiii. Hereditary degenerative retinal disorders such as retinitis pigmentosa. xiv. Clinically significant chronic haematoligical disease which may lead to priapism. xv. Bleeding disorders. xvi. Significant active petic ulceration. xvii. Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are potent inhibitors of CYP 3A4. xviii. Concomitant use of of vardenafil with potent CYP 3A4 inhibitors ketoconazole and itaconazole (oral form) is contra-indicated in men older than 75 years. xix. Patients deemed unable to comply with the requirments of the protocol. xx. Patients who have been on testosterone treatment in the past. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in endothelial function as measured by laser doppler imaging |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
BMI, waist circumference, glycaemic control (HbA1c), lipids and blood pressure CRP, |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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 | No |
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
|
End of trial will be when the last patient has completed the 54 week follow-up |
|
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 | 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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 29 |