The Effects of Long term testosterone supplementation In testosterone deficient men on Quality of life, Sarcopenia, cognitive function, Obesity and vasculaR ageing

ISRCTN ISRCTN23688581
DOI https://doi.org/10.1186/ISRCTN23688581
Secondary identifying numbers NTR31
Submission date
16/05/2005
Registration date
16/05/2005
Last edited
27/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marielle H Emmelot-Vonk
Scientific

Julius Centrum
UMC Utrecht
Huispostnr. FAC 5.02
P.O. Box 85500
Utrecht
3508 BA
Netherlands

Phone +31 (0)30 250 9291
Email m.h.emmelotvonk@azu.nl

Study information

Study designRandomised, placebo controlled, parallel group, double blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
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
Study acronymThe ELIQSOR study
Study objectivesSerum 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(s)The Institutional Review Board of the University Medical Center Utrecht approved the study protocol.
Health condition(s) or problem(s) studiedAge-related decline of testosterone
InterventionFour capsules of 40 mg testosterone undecanoate (TU) or placebo will be administered daily for 26 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Testosterone
Primary outcome measureFunctional mobility and quality of life.
Secondary outcome measures1. 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 study start date01/01/2004
Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupSenior
SexMale
Target number of participants240
Key inclusion criteria1. Men with testosterone level below the 50th percentile cut-off point (study population-based testosterone distribution)
2. Age more than 60 years
Key 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 six months before study
Date of first enrolment01/01/2004
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Julius Centrum
Utrecht
3508 BA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (The Netherlands)
University/education

Department of Geriatrics
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "ROR" https://ror.org/04pp8hn57

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Protocol 03/08/2006 Yes No
Results article 01/12/2007 Yes No
Results article 02/01/2008 Yes No

Editorial Notes

27/10/2022: Internal review.