Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000482662
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
How androgens exert their anabolic effects.
Interaction of testosterone and growth hormone at the hepatic level.
Scientific title
How androgens exert their anabolic effects:
Interaction of testosterone and growth hormone at the hepatic level in men with hypogonadism or hypopituitarism.
Universal Trial Number (UTN)
Trial acronym
oral testosterone study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Men with hypogonadism 603 0
Men with hypopituitarism 604 0
Condition category
Condition code
Metabolic and Endocrine 676 676 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
oral micronised testosterone 5 - 40 mg daily for 2 - 5 periods of 14 days.
transdermal testosterone (Androderm) 5mg daily for 1 -3 periods of 14 days.
recominant human growth hormone (GH)(Humatrope) 0.5 mg daily for 18 weeks (GH deficient subjects only!)
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 816 0
Biochemical markers of GH-IGF-axis and bone turnover
Timepoint [1] 816 0
At baseline and after each 14 day treatment period
Primary outcome [2] 817 0
Measurements of substrate metabolism and protein turnover
Timepoint [2] 817 0
At baseline and after each 14 day treatment period
Secondary outcome [1] 1628 0
None
Timepoint [1] 1628 0

Eligibility
Key inclusion criteria
Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)
Minimum age
Not stated
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 748 0
Government body
Name [1] 748 0
NHMRC
Country [1] 748 0
Australia
Primary sponsor type
Hospital
Name
Department of Endocrinology, St Vincents Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 619 0
None
Name [1] 619 0
none
Address [1] 619 0
Country [1] 619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1967 0
Garvan Institute of Medical Research
Ethics committee address [1] 1967 0
Ethics committee country [1] 1967 0
Australia
Date submitted for ethics approval [1] 1967 0
Approval date [1] 1967 0
Ethics approval number [1] 1967 0

Summary
Brief summary
Observations from previous studies suggest that the full action of GH requires the presence of male hormones like Testosterone (T). We will test the hypothesis that T enhances GH effect acting on the liver. We will compare the body protein production after delivering T exclusively to the liver (capsules) and to peripheral tissues (patch).
The first phase (11 weeks, 6 visits) aims to find the T dose which exposes the liver to normal/physiological T levels.
The second phase (16 weeks, 5 visits) will compare the effect of delivering T to the liver and to peripheral tissues.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36192 0
Address 36192 0
Country 36192 0
Phone 36192 0
Fax 36192 0
Email 36192 0
Contact person for public queries
Name 9706 0
Dr Ken Ho
Address 9706 0
Professor of Medicine
Head
Pituitary Research Unit
Garvan Institute Chairman
Department of Endocrinology
Garvan Institute of Medical Research
St Vincent's Hospital
384 Victoria Street
Darlinghurst NSW 2010
Country 9706 0
Australia
Phone 9706 0
+61 2 92958203
Fax 9706 0
+61 2 92958411
Email 9706 0
[email protected]
Contact person for scientific queries
Name 634 0
Dr. Vita Birzniece
Address 634 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 634 0
Australia
Phone 634 0
+61 2 9295 8486
Fax 634 0
Email 634 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIOral low-dose testosterone administration induces whole-body protein anabolism in postmenopausal women: a novel liver-targeted therapy2013https://doi.org/10.1530/eje-13-0406
N.B. These documents automatically identified may not have been verified by the study sponsor.