Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000537358
Ethics application status
Approved
Date submitted
26/09/2008
Date registered
24/10/2008
Date last updated
24/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metabolic effects of oestrogen compounds in men with low testosterone
Scientific title
Metabolic effects of SERMs (Selective Oestrogen Receptor Modulators) in hypogonadal men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic effects in men with low testosterone 3758 0
Condition category
Condition code
Metabolic and Endocrine 3939 3939 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Raloxifene (120 mg) as 2 oral tablets a day for 6 months
Intervention code [1] 3472 0
Other interventions
Comparator / control treatment
placebo (sugar pill), 2 tablets a day for 6 month
Control group
Placebo

Outcomes
Primary outcome [1] 4836 0
Growth hormone (GH) secretion after arginine stimulation, measured by GH Elisa kit, Bioclone Australia
Timepoint [1] 4836 0
At baseline and after 1 and 6 months of treatment
Secondary outcome [1] 8161 0
Whole body protein turnover by leucine turnover technique.
Timepoint [1] 8161 0
At baseline and after 1 and 6 months of treatment
Secondary outcome [2] 8262 0
Fat and lean body mass by Dual energy xray absorptiometry (DEXA).
Timepoint [2] 8262 0
At baseline and after 1 and 6 months of treatment
Secondary outcome [3] 8263 0
Measurements of fat oxidation by indirect calorimetry
Timepoint [3] 8263 0
At baseline and after 1 and 6 months of treatment
Secondary outcome [4] 8264 0
Biochemical markers of growth hormone - insulin-like growth factor I (GH-IGFI) axis measured by radioimmuno assay.
Timepoint [4] 8264 0
At baseline and after 1 and 6 months of treatment

Eligibility
Key inclusion criteria
Hypogonadism (prostate cancer patients on androgen deprivation therapy for at least 6 months)
Minimum age
40 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Androgen deprivation for less than 6 months, metastasis, cancer in other tissues than prostate, diabetes, kidney and liver disease, deep vein thrombosis

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3935 0
Government body
Name [1] 3935 0
NHMRC (National Health & Medical Research Council)
Country [1] 3935 0
Australia
Primary sponsor type
Hospital
Name
Department of Endocrinology, St Vincent's Hospital
Address
390 Victoria St Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 3527 0
None
Name [1] 3527 0
Address [1] 3527 0
Country [1] 3527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6000 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 6000 0
390 Victoria St Darlinghurst, NSW 2010
Ethics committee country [1] 6000 0
Australia
Date submitted for ethics approval [1] 6000 0
Approval date [1] 6000 0
05/10/2007
Ethics approval number [1] 6000 0
H07/070

Summary
Brief summary
We aim to investigate the effects of raloxifene (SERM) in hypogonadal men on the growth hormone system and metabolism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28982 0
Address 28982 0
Country 28982 0
Phone 28982 0
Fax 28982 0
Email 28982 0
Contact person for public queries
Name 12139 0
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Address 12139 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
2010 NSW
Country 12139 0
Australia
Phone 12139 0
02 9295 8482
Fax 12139 0
02 9295 8481
Email 12139 0
[email protected]
Contact person for scientific queries
Name 3067 0
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Address 3067 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
Country 3067 0
Australia
Phone 3067 0
02 9295 8482
Fax 3067 0
02 9295 8481
Email 3067 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
No additional documents have been identified.