Overview

This trial is active, not recruiting.

Conditions hypogonadism, metabolic syndrome
Treatments testim, strength training, placebo
Phase phase 4
Sponsor Odense University Hospital
Start date April 2008
End date January 2010
Trial size 60 participants
Trial identifier NCT00700024, 030

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
testim
testim testosteron
50 mg/dose7day
(Experimental)
placebo
placebo gel
placebo
(Experimental)
training
strength training training
three times a week

Primary Outcomes

Measure
Lean body mass
time frame: january 2008-january 2010

Secondary Outcomes

Measure
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
time frame: january 2008-january 2010

Eligibility Criteria

Male participants from 65 years up to 78 years old.

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

Additional Information

Official title The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men
Principal investigator Marianne Andersen, Md, phd
Description The effect of testim and training in hypogonadal men.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Odense University Hospital.