ELDERLY HYPOGONADAL MEN WITH SARCOPENIA MedDRA version: 9.1 Level: LLT Classification code 10063024 Term: Sarcopenia
Conditions
Interventions
Trade Name: TESTOPATCH 2,4 mg / 24h, transdermal patch
Product Name: TESTOPATCH
Product Code: L0074
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - elderly men aged between 65 and 90 years - AMS ³ 37 - Serum BT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: - 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;Primary end point(s): Changes in body composition assessed by changes of lean body mass using whole body dual x-ray absorptiometry (DEXA) | — |
Countries
France
Outcome results
None listed