Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000290392
Ethics application status
Approved
Date submitted
4/06/2008
Date registered
10/06/2008
Date last updated
5/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Healthy Man Study: Development of Valid Diagnostic Criteria for Age-related Androgen Deficiency in Men
Scientific title
The Healthy Man Study: Development of Valid Diagnostic Criteria for Age-related Androgen Deficiency in Men
Secondary ID [1] 296011 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
androgen level 3226 0
Condition category
Condition code
Metabolic and Endocrine 3391 3391 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of serum androgen levels and their variablity over a time-period of three months (visit 1: day 0, visit 2: between day 2-4, visit 3: between day 5-12, visit 4: between day 20-40, visit 5: between day 80-100. At visit 1 and 2 three blood samples will be taken every 20-60 minutes. At visits 3-5 only one blood sample will be taken). Involved will be healthy man (self-assessment) over 40 years of age. All subjects undergo the same procedure.
Intervention code [1] 2967 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4287 0
reference ranges for testosterone in aging men, measured in serum samples using the LCMS method (liquid chromatography/ mass spectrometry).
Timepoint [1] 4287 0
5 sampling days over three months(visit 1: day 0, visit 2: between day 2-4, visit 3: between day 5-12, visit 4: between day 20-40, visit 5: between day 80-100. At visit 1 and 2 three blood samples will be taken every 20-60 minutes. At visits 3-5 only one blood sample will be taken).
Secondary outcome [1] 7226 0
evaluating the variability of testosterone levels in healthy men using LCMS measurements of serum samples at different timepoints of sampling
Timepoint [1] 7226 0
Intraday, interday, interweek, intermonth variability (visit 1: day 0, visit 2: between day 2-4, visit 3: between day 5-12, visit 4: between day 20-40, visit 5: between day 80-100. At visit 1 and 2 three blood samples will be taken every 20-60 minutes. At visits 3-5 only one blood sample will be taken).

Eligibility
Key inclusion criteria
self-assessment of being in very good or excellent health. The participants will be stratified in the age groups 40-50, 50-60, 60-70, over 70 years.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- self-assessment of not being in very good or excellent health
- medication which influences androgen metabolism

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
21/05/2008
Date of last participant enrolment
Anticipated
Actual
9/03/2010
Date of last data collection
Anticipated
Actual
10/03/2010
Sample size
Target
400
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 883 0
2139
Recruitment postcode(s) [2] 884 0
3168

Funding & Sponsors
Funding source category [1] 3450 0
Charities/Societies/Foundations
Name [1] 3450 0
mbf foundation (Medical benefits fund foundation)
Country [1] 3450 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
mbf foundation (Medical benefits fund foundation)
Address
Dr Saxon Smith
Medical Relations Officer
MBF Australia
Level 2, 50 Bridge St
SYDNEY NSW 2000
Country
Australia
Secondary sponsor category [1] 3092 0
None
Name [1] 3092 0
Address [1] 3092 0
Country [1] 3092 0
Other collaborator category [1] 301 0
University
Name [1] 301 0
Prof Rob McLachlan
Address [1] 301 0
Prince Henrys Institute of Medical research
PO Box 5152
Clayton 3168
Victoria
Country [1] 301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5478 0
Sydney South West Area Health Services (SSWAHS) Human research ethics committee- Concord Repatriation General Hospital(CRGH)
Ethics committee address [1] 5478 0
Mrs Virginia Turner,
executive officer
Sydney South West Area Health Services (SSWAHS) Human research ethics committee- Concord Repatriation General Hospital(CRGH)
Concord Repatriation General Hospital
Hospital Road
Concord 2139, NSW
Ethics committee country [1] 5478 0
Australia
Date submitted for ethics approval [1] 5478 0
05/09/2007
Approval date [1] 5478 0
28/11/2007
Ethics approval number [1] 5478 0
CH62/6/2007-099

Summary
Brief summary
The overall aim is to establish an objective, empirically and statistically valid basis for the biochemical confirmation of age-related Androgen deficiency in older Australian men. This will be based on development of an age-stratified reference panel of healthy middle-aged and older Australian men with good quality of life.
Trial website
none
Trial related presentations / publications
Gideon Satorius, Sasa Spasevska, Amanda Idan, Leo Turner, Elise Forbes, Anna Zamojskat, Carolyn A. Allan, Lam P. Ly, Ann J. Conway, Robert I. McLachlan, David J. Handelsman (2012) Clinical Endocrinology (2012), 77, 755-763
Public notes

Contacts
Principal investigator
Name 28643 0
Prof David Handelsman
Address 28643 0
Department of Andrology
Building 22
Concord Repatriation General Hospital
CONCORD NSW 2139
Country 28643 0
Australia
Phone 28643 0
+61297677222
Fax 28643 0
Email 28643 0
[email protected]
Contact person for public queries
Name 11800 0
Prof Professor David Handelsman
Address 11800 0
ANZAC research institute
Hospital Road
Concord, NSW 2139
Country 11800 0
Australia
Phone 11800 0
02 9767 9111
Fax 11800 0
02 9767 7221
Email 11800 0
[email protected]
Contact person for scientific queries
Name 2728 0
Prof Professor David Handelsman
Address 2728 0
ANZAC research institute
Hospital Road
Concord, NSW 2139
Country 2728 0
Australia
Phone 2728 0
02 9767 9111
Fax 2728 0
02 9767 7221
Email 2728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.