Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000283673
Ethics application status
Approved
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
29/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Testosterone in Obese Men Trial
Scientific title
A 12-month Randomised, Placebo-controlled Trial of Testosterone Replacement Therapy and Lifestyle Modification Versus Lifestyle Modification Alone on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Middle-Aged and Older Men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese Middle-Aged and Older Men with Borderline Androgen Deficiency 371 0
Testosterone deficiency in ageing males 2893 0
Condition category
Condition code
Diet and Nutrition 436 436 0 0
Obesity
Metabolic and Endocrine 437 437 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-month Randomised, Placebo-controlled Trial of Testosterone Replacement Therapy (Intramuscular Testosterone Undecanoate) and Lifestyle Modification.
Intervention code [1] 320 0
Treatment: Drugs
Comparator / control treatment
Lifestyle Modification Alone
Control group
Placebo

Outcomes
Primary outcome [1] 498 0
Change in visceral fat
Timepoint [1] 498 0
After 52 weeks of intervention
Secondary outcome [1] 1070 0
Change in visceral fat
Timepoint [1] 1070 0
After 52 weeks of intervention
Secondary outcome [2] 1071 0
Body Composition (Total Body Fat Mass and Fat Free Mass)
Timepoint [2] 1071 0
At 0 and 52 weeks
Secondary outcome [3] 1072 0
Vascular Function (Pulse Wave Velocity)
Timepoint [3] 1072 0
At 0 and 52 weeks
Secondary outcome [4] 1073 0
Metabolic (Insulin Resistance and Lipid Profiles)
Timepoint [4] 1073 0
At 0, 26 and 52 weeks
Secondary outcome [5] 1074 0
Coagulation profiles
Timepoint [5] 1074 0
At 0, 6, 26, and 52 weeks.

Eligibility
Key inclusion criteria
BMI between 30-39.9 kg/m2 and WC equal to or greater than102cm, Serum total Testosterone <12nM.
Minimum age
40 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers, Significant medical condition, Sleep Apnoea, Contra-indications to Testosterone therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes provided by study drug manufacturer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence (by study drug manufacturer)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 488 0
Other
Name [1] 488 0
PHIMR
Country [1] 488 0
Australia
Funding source category [2] 489 0
Commercial sector/Industry
Name [2] 489 0
Schering AG
Country [2] 489 0
Australia
Primary sponsor type
Government body
Name
PHIMR
Address
Prince Henry's Institute. Level 3, Block E, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3168
Po Box 5152, Clayton, Vic, 3168
Country
Australia
Secondary sponsor category [1] 393 0
None
Name [1] 393 0
Nil
Address [1] 393 0
Country [1] 393 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35708 0
Address 35708 0
Country 35708 0
Phone 35708 0
Fax 35708 0
Email 35708 0
Contact person for public queries
Name 9509 0
Sr. Elise Forbes
Address 9509 0
Prince Henry's Institute of Medical Research
Monash Medical Centre
Level 3 Block E
246 Clayton Road
Clayton VIC 3168
Country 9509 0
Australia
Phone 9509 0
+ 61 3 95943554
Fax 9509 0
+ 61 3 95943558
Email 9509 0
elise.forbes@princehenrys.org
Contact person for scientific queries
Name 437 0
Dr. Carolyn Allan
Address 437 0
Prince Henry's Institute of Medical Research
Monash Medical Centre
Level 3 Block E
246 Clayton Road
Clayton VIC 3168
Country 437 0
Australia
Phone 437 0
+ 61 3 95943004
Fax 437 0
+ 61 3 95943558
Email 437 0
carolyn.allan@princehenrys.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.