Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

Phase 4

• Conditions: Hypogonadism; Metabolic Syndrome
• Interventions: Drug: placebo; Drug: Testim; Behavioral: Strength training

• Registration Number: NCT00700024
• Lead Sponsor: Odense University Hospital

Brief Summary

The purpose of this study is to determine the effect of training and testim on Hypogonadism.

Detailed Description

The effect of testim and training in hypogonadal men.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21
• Primary Completion: 2010-01
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Male 65-78
• Bioavailable testosterone < 7.3 nmol/L
• Waist > 94 cm

Exclusion Criteria

• Haematocrit > 0.50
• Known c. prostate or PSA > 3 Myg/L
• Known malignant disease
• Alcohol or drug abuse
• BMI > 40 kg/m2
• Use of 5 alpha reductance inhibitors
• Plan to father children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo
1	Testim	testim
3	Strength training	training

Primary Outcome Measures

Name	Time	Method
Lean body mass	january 2008-january 2010

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone	january 2008-january 2010

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark