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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.


- candidate number0
- NTR NumberNTR31
- ISRCTNISRCTN23688581
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR14-dec-2004
- Secondary IDs014-91-063 (NWO) 
- Public TitleThe 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.
- Scientific TitleThe 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.
- ACRONYMThe ELIQSOR study (The Effects of Long term testosterone supplementation In testosterone deficient men on Quality of life, Sarcopenia, cognitive function, Obesity and vasculaR ageing).
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedComplications, Testosteron
- Inclusion criteriaMen with testosterone level below the 50th percentile cut-of point (study population-based testosterone distribution) and age > 60 years.
- Exclusion criteria1. 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 6 months before study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-apr-2005
- Target number of participants240
- InterventionsFour capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.
- Primary outcomeFunctional Mobility and Quality of Life.
- Secondary outcomeBody Composition, Cognitive Function, Aortic Stiffness and Cardiovascular Risk Factors, Bone Mineral Density and Safety (Prostate, Liver Enzymes and Haematological Parameters).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Marielle H. Emmelot-Vonk
- CONTACT for SCIENTIFIC QUERIESDr. PhD. Yvonne T. Schouw, van der
- Sponsor/Initiator Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Department of Geriatrics
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsJAMA. 2008 Jan 2;299(1):39-52.
- Brief summarySerum testosterone levels decline gradually after the age of 50 year. This decline coincides with increasing sigh and symptoms of aging, including tiredness and lack of energy, diminished libido, erectily 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 randomized, 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, hematological parameters) in ageing men with an age-related decline of testosterone.
- Main changes (audit trail)
- RECORD5-jul-2005 - 2-jul-2008


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