Testosterone, aging and cognitive functioning
| ISRCTN | ISRCTN42645787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42645787 |
| Protocol serial number | A300413; NTR404 |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Erasmus Medical Centre (The Netherlands) |
- Submission date
- 28/02/2007
- Registration date
- 28/02/2007
- Last edited
- 15/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J W van Strien
Scientific
Scientific
Erasmus Univeristy Rotterdam
Psychology Institute
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 408 8787 |
|---|---|
| vanstrien@fsw.eur.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled, clinical trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study acronym | OLDER |
| Study objectives | Recent research showed a correlation between age related changes in hormone levels and cognitive decline and the emergence of Alzheimer disease in both men and women. Most research however is conducted in women. The aim of this study is to further investigate the relation between testosterone level and cognitive functioning in older men. In order to determine testosterone level, total-, sex hormone-binding globulin (SHBG)- and albumin bound and bioavailable testosterone will be measured. Hypothesis: Serum testosterone levels in men will be related to basic cognitive functions, such as mental processing speed and cognitive control. |
| Ethics approval(s) | Received from the local ethics committee (Medisch Ethische Toetsings Commissie Erasmus MC) on the 28th February 2005 (ref: 2005-071). |
| Health condition(s) or problem(s) studied | Benign prostatic hyperplasia (BPH), fertility problems |
| Intervention | Three cognitive computer tests are aimed to measure basal information processing speed, ability to suppress irrelevant stimuli and visuospatial perception, respectively. Two out-patient groups will be included: 1. BPH-patients in the age of 55 to 75, and 2. Patients with fertility symptoms in the age of 20 to 45 years Please note that this study was closed on the 19th February 2007. |
| Intervention type | Other |
| Primary outcome measure(s) |
We expect a correlation between serum level testosterone and basic cognitive functions such as cognitive speed and cognitive control. |
| Key secondary outcome measure(s) |
The relative contributions of age and testosterone level to cognitive functions will be established. |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Age between 55 and 75 or age between 20 and 45 2. Urological complaints suspected to be benign prostatic hyperplasia (BPH) or fertility symptoms 3. Subjective healthy impression |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 21/03/2005 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Univeristy Rotterdam
Rotterdam
3000 DR
Netherlands
3000 DR
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 |
