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 |
| Protocol serial number | NTR31 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Scientific
Julius Centrum
UMC Utrecht
Huispostnr. FAC 5.02
P.O. Box 85500
Utrecht
3508 BA
Netherlands
| Phone | +31 (0)30 250 9291 |
|---|---|
| m.h.emmelotvonk@azu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | The ELIQSOR study |
| Study objectives | 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(s) | The Institutional Review Board of the University Medical Center Utrecht approved the study protocol. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Testosterone |
| Primary outcome measure(s) |
Functional mobility and quality of life. |
| Key secondary outcome measure(s) |
1. Body composition |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target sample size at registration | 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Julius Centrum
Utrecht
3508 BA
Netherlands
3508 BA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2007 | Yes | No | ||
| Results article | 02/01/2008 | Yes | No | ||
| Protocol article | Protocol | 03/08/2006 | Yes | No |
Editorial Notes
27/10/2022: Internal review.
