Older Men and Testosterone
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|ClinicalTrials.gov Identifier: NCT00119483|
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : September 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Nebido (Testosterone Undecanoate)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||December 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119483
|Department of Medicine, University Hospital of North Norway|
|Tromsø, Norway, 9038|
|Principal Investigator:||Johan Svartberg, MD, PhD||University Hospital of North Norway|