Odense Androgen Study - The effect of Testim vs strength training i a populationbased, randomised, placebocontrolled, doubleblinded study in hypogonadal men - OAS/testim

• Conditions: This study will prodvide information on the Metabolic syndrome and the relationship with hypogonadism in older men.; MedDRA version: 9.1Level: LLTClassification code 10021011Term: Hypogonadism male

• Registration Number: EUCTR2007-001690-28-DK
• Lead Sponsor: Dept of Endocrinology, Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Male 60-78 years
Biochemically verified hypogonadism
Waist > 94 cm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hematorit > 0,50
Known prostate cancer or PSA > 4
known malignant disease
Alcohol or Drug abuse
BMI > 40

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) The effect of Testosterone (testim) in a randomized doubleblinded plcebocontrolled study on body composition, liverfat and cardiovascular risk parameters<br>2) The Effect of training on body composition, liverfat and cardiovascular risk parameters<br>3)Compare the effect of testosterone and training on body composition, liverfat and cardiovascular risk parameters<br>4) Investigate the effect of training on the serum level of Testosterone;Secondary Objective: ;Primary end point(s): Lean Body Mass