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ISRCTN
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ISRCTN23688581
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ClinicalTrials.gov identifier
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Public title
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The Effects of Long term testosterone supplementation In testosterone deficient men on Quality of life, Sarcopenia, cognitive function, Obesity and vasculaR ageing
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Scientific title
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The effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, and bone mineral density in ageing men with an age-related decline of testosterone
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Acronym
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The ELIQSOR study
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Serial number at source
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NTR31
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Study hypothesis
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Serum testosterone levels decline gradually after the age of 50 years. This decline coincides with increasing signs and symptoms of aging, including tiredness and lack of energy, diminished libido, erectile dysfunction, reduced muscle mass and strength, reduced bone density, depression and diminished well-being. Androgen replacement might have a beneficial influence on these organs and functions in the aging male, but there are only limited clinical data available on the effects of testosterone replacement in males with a age-related decline of testosterone. Moreover, the results of this data are conflicting, insignificant or the study design has been insufficient.
Therefore, we conducted this randomised, placebo-controlled trial to assess the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, bone mineral density and safety (prostate, liver enzymes, haematological parameters) in ageing men with an age-related decline of testosterone.
The hypothesis is that testosterone supplementation improves functional mobility, quality of life, body composition, cognitive function, aortic stiffness and cardiovascular risk factors, and bone mineral density compared to placebo.
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Ethics approval
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The Institutional Review Board of the University Medical Center Utrecht approved the study protocol.
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Study design
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Randomised, placebo controlled, parallel group, double blinded trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Age-related decline of testosterone
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Participants - inclusion criteria
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1. Men with testosterone level below the 50th percentile cut-off point (study population-based testosterone distribution)
2. Age more than 60 years
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/04/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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240
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Interventions
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Four capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.
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Primary outcome measure(s)
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Functional mobility and quality of life.
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Secondary outcome measure(s)
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1. Body composition
2. Cognitive function
3. Aortic stiffness and cardiovascular risk factors
4. Bone mineral density and safety (prostate, liver enzymes and haematological parameters)
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16887030
Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/18035098
2. http://www.ncbi.nlm.nih.gov/pubmed/18167405
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Contact name
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Dr
Marielle H
Emmelot-Vonk
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Address
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Julius Centrum
UMC Utrecht
Huispostnr. FAC 5.02
P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 BA
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Country
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Netherlands
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Tel
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+31 (0)30 250 9291
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Email
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m.h.emmelotvonk@azu.nl
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Sponsor
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University Medical Centre Utrecht (UMCU) (The Netherlands)
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Address
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Department of Geriatrics
P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Sponsor website:
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http://www.umcutrecht.nl/zorg/
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Date applied
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16/05/2005
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Last edited
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02/04/2008
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Date ISRCTN assigned
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16/05/2005
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