Older Men and Testosterone
|First Received Date ICMJE||July 5, 2005|
|Last Updated Date||September 2, 2011|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00119483 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Older Men and Testosterone|
|Official Title ICMJE||Not Provided|
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.
Older men and testosterone (Short version of the study protocol)
Cohort study "How is life as an elderly man when serum testosterone is subnormal?"
To investigate whether subnormal testosterone levels in elderly men (60-80 years old) is associated with clinical symptoms and/or disease, the investigators will ask men with normal testosterone (>11.3 nmol/l) and men with subnormal testosterone levels (<11.3 nmol/l) who participated in the last Tromsø study 2001 to participate in this study.
Screening: Blood pressure, clinical examination including prostate examination, blood samples (testosterone, SHBG, LH, FSH, albumin and PSA).
Aproximately 350 men had subnormal testosterone levels in the last Tromsø study and the researchers will try to include up to 200 men who still have subnormal testosterone levels and up to 200 age matched men who still have normal testosterone levels.
Symptoms: Aging Male Symptom Score
Muscle strength and function: The researchers will investigate muscle strength, peak torque with isokinetic dynamometry in the knee joint and muscle function (gait, balance and movement); Grip Strength
The metabolic syndrome
Interventions study "Should subnormal testosterone levels be treated?"
To investigate whether older men with subnormal testosterone levels would benefit from physiological testosterone supplementation, the men with subnormal testosterone levels participating in the cohort study (approximately 150-200 men) will be asked to participate in a one year intervention study.
Randomization and treatment:
Double blind randomized (1:1) 1-year study. First injection at inclusion, second after 6 weeks, the third injection after 16 weeks, the fourth at 28 weeks and the last at 40 weeks. Active treatment is Nebido, 1000 mg testosteron undecanoate, a 4 ml intramuscular depot injection. Schering AS will supply the study with both Nebido and placebo (containing "castor oil" and "benzyl benzoate").
Registration of adverse events:
All adverse events will be recorded in the participants CRF. Serious adverse events will be reported according to regulations.
The above-described procedures for the cohort study will also be performed in the intervention study.
Testosterone levels, hematocrit, creatinine, ALAT and PSA will be controlled at every visit.
Object variables for both the cohort and intervention study
Psychosexual quality of life; Muscle strength
Muscle function; Body composition; Intraabdominal vs. subcutaneous fat distribution; CAG and GGN polymorphism in the androgen receptor gene; Bone mineral density; Per oral glucose tolerance test; Lipid profile/fat tolerance test; Neuropsychological test; Neuroendocrine regulation Sleep
Statistics and methods:
The study will be performed at the Clinical research ward at the University Hospital of North Norway.
Comparisons between the groups will be assessed with non-parametrical tests (Mann-Whitney U-test) or ANOVA with a significant level p<0.05. In the intervention study delta-values will be used to assess changes during treatment and differences between the study groups. SPSS will be used as statistical program.
Inclusion of patients to the cohort study should be completed during 2006 and the intervention study should be completed during 2007.
Research partner Johan Svartberg, Department of Medicine, University Hospital of North Norway, Tromsø, Norway is the responsible investigator.
Partners: Professor Rolf Jorde and John-Bjarne Hansen MD, PhD, Department of Medicine, Professor Johan Sundsfjord, Department of Clinical Chemistry and Professor Knut Waterloo, Department of Neurology, University Hospital of North Norway, Tromsø, Norway and Professor Aleksander Giwercman, Scanian Andrology Center, Department of Urology, Malmö University Hospital, Sweden.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Nebido (Testosterone Undecanoate)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||60 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Norway|
|NCT Number ICMJE||NCT00119483|
|Other Study ID Numbers ICMJE||Eldre menn og testosteron|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||University Hospital of North Norway|
|Study Sponsor ICMJE||University Hospital of North Norway|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University Hospital of North Norway|
|Verification Date||September 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP