Condition category
Pregnancy and Childbirth
Date applied
28/02/2007
Date assigned
28/02/2007
Last edited
15/10/2008
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 J W van Strien

ORCID ID

Contact details

Erasmus Univeristy Rotterdam
Psychology Institute
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 408 8787
vanstrien@fsw.eur.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A300413; NTR404

Study information

Scientific title

Acronym

OLDER

Study hypothesis

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

Received from the local ethics committee (Medisch Ethische Toetsings Commissie Erasmus MC) on the 28th February 2005 (ref: 2005-071).

Study design

Non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

21/03/2005

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

200

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

21/03/2005

Recruitment end date

01/03/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Univeristy Rotterdam
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (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

Publication citations

Additional files

Editorial Notes