Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001045606
Ethics application status
Approved
Date submitted
19/09/2014
Date registered
29/09/2014
Date last updated
29/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
How androgens exert their anabolic effects: effects of oral testosterone on protein metabolism in healthy men.
Scientific title
How androgens exert their anabolic effects.
Effects of oral testosterone on protein metabolism in healthy men.
Secondary ID [1] 285369 0
Nil
Universal Trial Number (UTN)
U1111-1161-9688
Trial acronym
Oral testosterone study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Protein metabolism in healthy men 293101 0
Condition category
Condition code
Metabolic and Endocrine 293375 293375 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral micronised testosterone 40 mg daily for 14 days.
Adherence to treatment will be monitored by drug return.
Intervention code [1] 290284 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293203 0
Protein turnover by using stable isotopes (leucine)
Timepoint [1] 293203 0
2 weeks
Secondary outcome [1] 310578 0
Nil
Timepoint [1] 310578 0
Nil

Eligibility
Key inclusion criteria
Healthy men
Minimum age
60 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Endocrine disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
na
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
na
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Anova.
Sample size has been derived from previously published studies in hypogonadal men and postmenopausal women, where similar dose of oral testosterone significantly modified protein turnover.
Extrapolating from these studies with power of 80% a sample size of at least 8 will give p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3004 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 8717 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 289982 0
Government body
Name [1] 289982 0
NHMRC
Country [1] 289982 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Garvan Institute
Address
Victoria St Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 288667 0
None
Name [1] 288667 0
Address [1] 288667 0
Country [1] 288667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291691 0
Western Sydney Local Health District HREC
Ethics committee address [1] 291691 0
WSLHD, Westmead Hospital,
Darcy Rd
Westmead, NSW 2145
Ethics committee country [1] 291691 0
Australia
Date submitted for ethics approval [1] 291691 0
Approval date [1] 291691 0
11/09/2014
Ethics approval number [1] 291691 0

Summary
Brief summary
Observations from previous studies suggest that testosterone acts on liver to induce protein anabolic effect. We will test the hypothesis that testosterone by acting on the liver, preserves protein loss in healthy men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51546 0
Dr Vita Birzniece
Address 51546 0
UWS Clinical School and Research Centre
Blacktown Hospital,
18 Blacktown Rd
Blacktown, NSW 2148
Country 51546 0
Australia
Phone 51546 0
+61 2 98516059
Fax 51546 0
Email 51546 0
v.birzniece@uws.edu.au
Contact person for public queries
Name 51547 0
Dr Vita Birzniece
Address 51547 0
UWS Clinical School and Research Centre
Blacktown Hospital
18 Blacktown Rd
Blacktown, NSW 2148
Country 51547 0
Australia
Phone 51547 0
+61 2 98516059
Fax 51547 0
Email 51547 0
v.birzniece@uws.edu.au
Contact person for scientific queries
Name 51548 0
Dr Vita Birzniece
Address 51548 0
UWS Clinical School and Research Centre
Blacktown Hospital
18 Blacktown Rd
Blacktown, NSW 2148
Country 51548 0
Australia
Phone 51548 0
+61 2 98516059
Fax 51548 0
Email 51548 0
v.birzniece@uws.edu.au

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.