The Effects of Long term testosterone supplementation In testosterone deficient men on Quality of life, Sarcopenia, cognitive function, Obesity and vasculaR ageing
- Conditions
- Age-related decline of testosteroneUrological and Genital Diseases
- Registration Number
- ISRCTN23688581
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (The Netherlands)
- Brief Summary
2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/16887030 Protocol 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18035098 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18167405
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 240
1. Men with testosterone level below the 50th percentile cut-off point (study population-based testosterone distribution)
2. Age more than 60 years
1. Severe diseases or conditions interfering with conduct of study
2. Conditions for which increase of androgen-like substances are contra-indicated
3. Symptomatic prostate hypertrophy, serious renal and liver function disturbances, heart failure, prostate or breast cancer
4. Diabetes mellitus de novo or already treated. A fasting capillary glucose level of 6.9 mmol/l or higher.
5. Diseases of adrenal gland, hypothalamo-pituitary-adrenal or -gonadal axis
6. Use of steroids or androgens six months before study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional mobility and quality of life.
- Secondary Outcome Measures
Name Time Method <br> 1. Body composition<br> 2. Cognitive function<br> 3. Aortic stiffness and cardiovascular risk factors<br> 4. Bone mineral density and safety (prostate, liver enzymes and haematological parameters)<br>