Testosterone and Weight Loss

Obesity in Men Clinical Trial

Official title:

Effect of Testosterone and Diet on Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616732
• Other study ID #: 04495
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: June 3, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI >30

Exclusion Criteria:

• contraindications to testosterone therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity in Men

Intervention

Drug:
• Testosterone
TU im
• placebo
placebo im

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight		12 months	No