Testosterone and Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mathis Grossmann, Austin Health
ClinicalTrials.gov Identifier:
NCT01616732
First received: June 8, 2012
Last updated: June 3, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Obesity in Men
Drug: Testosterone
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Testosterone and Diet on Weight

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2013
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: testosterone
against placebo
Drug: Testosterone
TU im
Placebo Comparator: placebo Drug: placebo
placebo im

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >30

Exclusion Criteria:

  • contraindications to testosterone therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616732

Locations
Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
  More Information

Responsible Party: Mathis Grossmann, Associate Professor, Austin Health
ClinicalTrials.gov Identifier: NCT01616732     History of Changes
Other Study ID Numbers: 04495 
Study First Received: June 8, 2012
Last Updated: June 3, 2016
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on July 27, 2016