|- candidate number||1218|
|- NTR Number||NTR404|
|- Date ISRCTN created||28-feb-2007|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||A300413 |
|- Public Title||Testosterone, aging and cognitive functioning.|
|- Scientific Title||Testosterone, aging and cognitive functioning.|
|- hypothesis||Serum testosterone levels in men will be related to basic cognitive functions, such as mental processing speed and cognitive control.|
|- Healt Condition(s) or Problem(s) studied||Benign prostatic hyperplasia (BPH), Fertility problems|
|- Inclusion criteria||1. Age between 55 and 75 or age between 20 and 45;|
2. Urological complaints suspected to be BPH or fertility symptoms;
3. Subjective healthy impression.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||21-mrt-2005|
|- planned closingdate||1-mrt-2007|
|- Target number of participants||200|
|- Interventions||Computer tests.|
|- Primary outcome||We expect a correlation between serum level testosterone and basic cognitive functions such as cognitive speed and cognitive control.|
|- Secondary outcome||The relative contributions of age and testosterone level to cognitive functions will be established.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.W. Strien, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. C.H. Bangma|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Urology|
|- Brief summary||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-, SHBG- and albumin bound and bioavailable testosterone will be measured.
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 55-75, and
2. patients with fertility symptoms in the age of 20-45 years.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 16-nov-2009|