E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ELDERLY HYPOGONADAL MEN WITH SARCOPENIA |
|
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 | 10063024 |
E.1.2 | Term | Sarcopenia |
|
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 whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will modify their body lean mass |
|
E.2.2 | Secondary objectives of the trial |
- To determine whether testosterone will improve their physical performance as assessed by the Short Physical Performance Battery (SPPB) - To determine whether testosterone will increase their muscle strength as measured by the Hand-grip test To determine whether testosterone will increase their body lean mass as measured by impedancemetry - To determine whether testosterone will improve their quality of life as assessed by Ageing Males Symptoms (AMS) and Short Form Health rating survey (SF-12) - To assess the androgenic and pituitary hormonal profile under treatment - To assess the safety profile of Testopatch in the elderly |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- elderly men aged between 65 and 90 years - AMS ³ 37 - Serum BT < 0.90 ng/mL - Short Physical Performance Battery (SPPB) value between 4 and 9 - Body lean mass evaluation by Impedancemetry < -2 DS from normal value - Serum total PSA £ 3 ng/mL - Able to complete an informed consent |
|
E.4 | Principal exclusion criteria |
- Known acute or chronic prostate pathology, and/or PSA > 3 ng/mL, and/or suspicion of prostate cancer; familial history of prostate cancer - Male breast cancer - Severe cardiovascular, respiratory, hepatic, renal failure, or metabolic diseases/disorders - Unstable angina, NYHA class III or IV congestive heart failure, or myocardial infarction within 3 months of entry - Blood pressure > 160/90 mm Hg - Hematocrit > 48% - ALT and/or AST twice above the upper limit - Uncontrolled hyper or hypothyroidism - Limiting neuromuscular, joint or bone disease - Documented sleep apnea - Dementia, cognitive impairment or any psychiatric disease affecting subject’s ability to provide informed consent - Rheumatoid arthritis, cirrhosis or active hepatitis - History of stroke causing persistent motor deficit - Uncontroled diabetic patients (type I or II) - Acute illness in the prior 30 days - Severe disability limiting strength or physical function testing - Inability to perform hang-grip test - Generalized dermatological disorders that might affect testosterone absorption or local tolerability assessment (hypertrichosis, psoriasis, eczema) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in body composition assessed by changes of lean body mass using whole body dual x-ray absorptiometry (DEXA) |
|
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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 | 4 |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |