Transdermal testosterone supplementation in elderly hypogonadal men with sarcopenia: effects on muscle function, physical performance, body composition and quality of life.”A randomized, double-blind, placebo-control, parallel-group study on 150 patients.
- Conditions
- ELDERLY HYPOGONADAL MEN WITH SARCOPENIAMedDRA version: 9.1Level: LLTClassification code 10063024Term: Sarcopenia
- Registration Number
- EUCTR2006-006354-98-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 150
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method