The Healthy Man Study: Development of Valid Diagnostic Criteria for Age-related Androgen Deficiency in Me

Not Applicable

Completed

• Conditions: androgen level; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12608000290392
• Lead Sponsor: mbf foundation (Medical benefits fund foundation)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 400

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.

Exclusion Criteria

- self-assessment of not being in very good or excellent health
- medication which influences androgen metabolism

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reference ranges for testosterone in aging men, measured in serum samples using the LCMS method (liquid chromatography/ mass spectrometry).[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 Measures

Name	Time	Method
evaluating the variability of testosterone levels in healthy men using LCMS measurements of serum samples at different timepoints of sampling[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).]