Testosterone, aging and cognitive functioning

ISRCTN	ISRCTN42645787
DOI	https://doi.org/10.1186/ISRCTN42645787
Secondary identifying numbers	A300413; NTR404

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

Erasmus Univeristy Rotterdam
Psychology Institute
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 408 8787
Email	vanstrien@fsw.eur.nl

Study information

Study design	Non-randomised, non-controlled, clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Not specified
Study type	Treatment
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	We expect a correlation between serum level testosterone and basic cognitive functions such as cognitive speed and cognitive control.
Secondary outcome measures	The relative contributions of age and testosterone level to cognitive functions will be established.
Overall study start date	21/03/2005
Completion date	01/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	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

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Urology
P.O. Box 1738
Rotterdam
3000 RD
Netherlands

Website	http://www.erasmusmc.nl/
"ROR"	https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan