Older Men and Testosterone
Male hypogonadism is a clinical situation characterized by a low serum testosterone level in combination with a diversity of symptoms and signs such as reduced libido and vitality, decreased muscle mass, increased fat mass and depression. Similar symptoms in combination with subnormal testosterone levels are seen in some elderly men. Low testosterone levels are associated with known cardiovascular risk factors, and men with diabetes and stroke have lower testosterone levels than healthy men. Even though several publications have suggested that testosterone treatment in hypogonadal men may have beneficial effects, it is still uncertain if testosterone substitution in the aging man is indicated. Despite this uncertainty the sale of testosterone has increased enormously the last few years.
We hypothesize that older men with subnormal testosterone levels have a varying degree of dysfunction/symptoms both physically and mentally, and that these dysfunction/symptoms can be improved with testosterone treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
- Quality of life (psycho-sexual)
- Muscle strength
- Body composition
- Muscle function
- Intra abdominal vs subcutanous fat mass.
- Bone density
- CAG and GGN polymorphy in the androgene receptor gene
- Glucose tolerance/insulin resistance
- Fat tolerance
- Neuroendocrine profile
- Neuropsychological profile
|Study Start Date:||September 2005|
|Study Completion Date:||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119483
|Department of Medicine, University Hospital of North Norway|
|Tromsø, Norway, 9038|
|Principal Investigator:||Johan Svartberg, MD, PhD||University Hospital of North Norway|