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

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00700024
• Other study ID #: 030
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 16, 2008
• Last updated: September 18, 2009
• Start date: April 2008
• Est. completion date: February 2010

Study information

• Verified date: September 2009
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

The effect of testim and training in hypogonadal men.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 78 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Testim
50 mg/dose7day

Behavioral:
• Strength training
three times a week

Drug:
• placebo
placebo

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean body mass		january 2008-january 2010	No
Secondary	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	No