Testosterone and Weight Loss

June 3, 2016 updated by: Mathis Grossmann, Austin Health

Effect of Testosterone and Diet on Weight

The investigators hypothesise that testosterone therapy will synergize with dietary intervention to achieve weight loss. Obese men will receive diet, and be randomised to either testosterone therapy or placebo. Primary outcomes will be weight and body composition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI >30

Exclusion Criteria:

  • contraindications to testosterone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo im
Active Comparator: testosterone
against placebo
Drug: Testosterone
TU im

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austin Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04495

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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