Condition category
Urological and Genital Diseases
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
02/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcutrecht.nl/zorg/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes