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Testosterone and Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616732
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity in Men Drug: Testosterone Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Testosterone and Diet on Weight
Study Start Date : April 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: testosterone
against placebo
Drug: Testosterone
TU im

Placebo Comparator: placebo Drug: placebo
placebo im

Primary Outcome Measures :
  1. weight [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI >30

Exclusion Criteria:

  • contraindications to testosterone therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616732

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Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mathis Grossmann, Associate Professor, Austin Health Identifier: NCT01616732     History of Changes
Other Study ID Numbers: 04495
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents