CompletedPhase 3ACTRN12606000404527

A randomised placebo-controlled trial of testosterone undecanoate in obese men as adjuvant therapy for a weight loss program


Sponsor

The Woolcock Institute of Medical Research

Enrollment

60 participants

Start Date

Sep 1, 2006

Study Type

Interventional

Conditions

Summary

This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena as adjunctive therapy for a weight loss programme. The aim of the study is to evaluate the additional effect of testosterone replacement on weight loss and motivation in obese (BMI>30kg/m2) men with obstructive sleep apnea undergoing a weight reduction program. The primary endopint is weight loss after 4.5 months with other secondary endpoints including body composition, anthropometry, physical activity, metabolic markers (eg insulin sensitivity, basal metabolic rate) and blood hormone concentrations.


Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether adding testosterone treatment to a weight loss program helps obese men lose more weight. Men aged 18 and older who are obese take either testosterone or a placebo alongside a structured weight loss program. Researchers track changes in weight, body composition, and health markers.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted o

This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted on an ambulatory basis and involve OSA subjects who are about to commence a standard weight reduction program. Once deemed eligible for the study, at a Screening visit, patients will report to the laboratory every 6 weeks for 18 weeks. They will receive three injections of testosterone (3000mg in total) undecanoate at 0, 6 and 12 weeks. In addition, whilst reporting patients will undergo a variety of assessments including overnight polysomnographies at weeks 0, 6 and 18 weeks. Patient will then reassessed in recovery, at one year


Locations(1)

Australia

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ACTRN12606000404527


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