Contact information
Type
Scientific
Primary contact
Dr Marielle H Emmelot-Vonk
ORCID ID
Contact details
Julius Centrum
UMC Utrecht
Huispostnr. FAC 5.02
P.O. Box 85500
Utrecht
3508 BA
Netherlands
+31 (0)30 250 9291
m.h.emmelotvonk@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR31
Study information
Scientific title
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
Acronym
The ELIQSOR study
Study hypothesis
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.
Ethics approval
The Institutional Review Board of the University Medical Center Utrecht approved the study protocol.
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Age-related decline of testosterone
Intervention
Four capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Testosterone
Primary outcome measures
Functional mobility and quality of life.
Secondary outcome measures
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)
Overall trial start date
01/01/2004
Overall trial end date
01/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men with testosterone level below the 50th percentile cut-off point (study population-based testosterone distribution)
2. Age more than 60 years
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
240
Participant exclusion criteria
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
Recruitment start date
01/01/2004
Recruitment end date
01/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Julius Centrum
Utrecht
3508 BA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (The Netherlands)
Sponsor details
Department of Geriatrics
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Protocol
Nakhai Pour HR, Emmelot-Vonk MH, Sukel-Helleman M, Verhaar HJ, Grobbee DE, van der Schouw YT, Double blind randomized placebo-controlled trial on the effects of testosterone supplementation in elderly men with moderate to low testosterone levels: design and baseline characteristics [ISRCTN23688581]., Trials, 2006, 7, 24, doi: 10.1186/1745-6215-7-24.
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Nakhai-Pour HR, Grobbee DE, Emmelot-Vonk MH, Bots ML, Verhaar HJ, van der Schouw YT, Oral testosterone supplementation and chronic low-grade inflammation in elderly men: a 26-week randomized, placebo-controlled trial., Am. Heart J., 2007, 154, 6, 1228.e1-7, doi: 10.1016/j.ahj.2007.09.001.
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Emmelot-Vonk MH, Verhaar HJ, Nakhai Pour HR, Aleman A, Lock TM, Bosch JL, Grobbee DE, van der Schouw YT, Effect of testosterone supplementation on functional mobility, cognition, and other parameters in older men: a randomized controlled trial., JAMA, 2008, 299, 1, 39-52, doi: 10.1001/jama.2007.51.