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
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
Trial website
Trial related presentations / publications
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
djh@anzac.edu.au
Contact person for public queries
Name 11800 0
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
djh@anzac.edu.au
Contact person for scientific queries
Name 2728 0
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
djh@anzac.edu.au

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.