E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
Does the anti-anginal effect of testosterone therapy in men with coronary ischaemia persist in the long term |
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E.2.2 | Secondary objectives of the trial |
Does testosteone therapy in men affect the levels of measurable atheroma? |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
PATIENT SELECTION CRITERIA Patients will be recruited from those under the care of consultant cardiologists within the North Trent network. . Inclusion Criteria. 1. Males over 20 years of age 2. With stable, chronic angina pectoris for > 1 month 3. With S-T segment depression of > 1mm within 12 minutes of the Bruce protocol 4. Willing and able to give informed consent and comply with the study protocol 5. Serum testosterone (<12nmol/L) |
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E.4 | Principal exclusion criteria |
Exclusion Criteria. 1. Use of androgen therapy or anabolic steroids within 6 months of entry into the study (i.e. screening visit/visit 1) or concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH), oxyphenbutazone 2. Contraindication to treatment with Nebido®. 3. Organic hypothalamic-pituitary pathology 4. Prostate specific antigen (PSA) ≥4ng/ml 5. Severe symptomatic benign prostatic hyperplasia 6. Patients actively or potentially trying to start a family or requiring fertility treatment 7. Suspicion of, current, or past history of breast or prostatic carcinoma 8. MI, CABG or PTCA in the last three months 9. Significant hepatic, respiratory, haematological or renal disease 10.Haematocrit >50% at entry to the study (i.e. screening visit/visit 1) 11.History of significant arrhythmia, WPW syndrome, or >1st degree heart block. CVA within the last three months 12. History of drug or alcohol abuse 13. Receiving other trial drugs within 12 weeks 14. Hypotension (systolic BP< 100 mm Hg) 15. Severe, malignant, complicated, renovascular, secondary, or uncontrolled hypertension (BP>180/114) 16. Hypercalcaemia 17. Nephrotic range proteinuria 18. Symptomatic obstructive sleep apnoea syndrome 19. With ECG abnormalities that preclude ST segment analysis (eg LBBB, AF) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in angina threshold as determined by exercise testing at the end of one year of testosterone therapy |
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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 | Information not present in EudraCT |
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 | 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 | 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.8.5 | 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 | Information not present in EudraCT |
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
|
|
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 | 6 |
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 | 6 |