Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000586415
Ethics application status
Approved
Date submitted
13/11/2007
Date registered
16/11/2007
Date last updated
16/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metabolic Effects of SERMs (Selective Oestrogen Receptor Modulators) in healthy men and healthy postmenopausal women
Scientific title
Metabolic Effects of SERMs (Selective Oestrogen Receptor Modulators) in healthy men and healthy postmenopausal women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic effects in healthy men and healthy postmenopausal women 2544 0
Condition category
Condition code
Metabolic and Endocrine 2644 2644 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Raloxifene 60mg and 120 mg daily and Tamoxifen 10 mg and 20 mg daily. Duration of treatment for each dose is 2 weeks with washout period of 2 weeks after cross over.
Intervention code [1] 2276 0
Other interventions
Comparator / control treatment
Cross over study. Oral administration of Raloxifene 60mg and 120 mg daily will be compared with Tamoxifen 10 mg and 20 mg daily.
Control group
Active

Outcomes
Primary outcome [1] 3554 0
Growth hormone (GH) secretion and response to stimuli, measurements of substrate metabolism by indirect calorimetry and protein turnover by leucine turnover technique.
Timepoint [1] 3554 0
At baseline and after each treatment period.
Secondary outcome [1] 5952 0
Biochemical markers of growth hormone - insulin-like growth factor I (GH-IGFI) axis
Timepoint [1] 5952 0
At baseline and after each treatment period.

Eligibility
Key inclusion criteria
Healthy postmenopausal women and healthy men the same age
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
obesity, diabetes, cancer, kidney or liver diseases, deep vein thrombosis

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/11/2006
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)
Recruitment postcode(s) [1] 495 0
2010

Funding & Sponsors
Funding source category [1] 2789 0
Government body
Name [1] 2789 0
NHMRC (National Health & Medical Research Council)
Country [1] 2789 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] 2519 0
None
Name [1] 2519 0
Address [1] 2519 0
Country [1] 2519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4708 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 4708 0
390 Victoria St Darlinghurst, NSW 2010
Ethics committee country [1] 4708 0
Australia
Date submitted for ethics approval [1] 4708 0
Approval date [1] 4708 0
13/10/2006
Ethics approval number [1] 4708 0
H06/047

Summary
Brief summary
We aim to investigate and compare the effects of raloxifene and tamoxifen (two most commonly used SERMs) in healthy men and women on the growth hormone system and metabolism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28179 0
Address 28179 0
Country 28179 0
Phone 28179 0
Fax 28179 0
Email 28179 0
Contact person for public queries
Name 11336 0
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Address 11336 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
2010 NSW
Country 11336 0
Australia
Phone 11336 0
02 9295 8482
Fax 11336 0
02 9295 8481
Email 11336 0
[email protected]
Contact person for scientific queries
Name 2264 0
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Address 2264 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
2010 NSW
Country 2264 0
Australia
Phone 2264 0
02 9295 8482
Fax 2264 0
02 9295 8481
Email 2264 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
EmbaseEstrogen receptor antagonism uncovers gender-dimorphic suppression of whole body fat oxidation in humans: Differential effects of tamoxifen on the GH and gonadal axes.2015https://dx.doi.org/10.1530/EJE-15-0426
N.B. These documents automatically identified may not have been verified by the study sponsor.