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Trial registered on ANZCTR


Registration number
ACTRN12611001093976
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
20/10/2011
Date last updated
20/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The neuroendocrine and metabolic effects of oestrogens
Scientific title
The neuroendocrine and metabolic effects of oestrogens in healthy postmenopausal women and men the same age
Secondary ID [1] 273245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine regulation of GH secretion by oestrogens 279005 0
Metabolic effects of oestrogens 279006 0
Condition category
Condition code
Metabolic and Endocrine 279190 279190 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Oestradiol 2 mg once daily orally for 2 weeks, followed by 4 weeks washout;
2) tamoxifen 20 mg once daily orally for 2 weeks, followed by 4 weeks washout;
3) letrozole 5 mg once daily orally for 2 weeks
Women take all 3 treatments, men take only tamoxifen and letrozole.
Intervention code [1] 269580 0
Treatment: Drugs
Comparator / control treatment
Patients act as their own control
Control group
Active

Outcomes
Primary outcome [1] 279826 0
Whole body fatty acid metabolism assessed by palmitate turnover technique.
Timepoint [1] 279826 0
Assessed after each 2 week intervention period, i.e. three times in women and twice in men.
Primary outcome [2] 279827 0
Liver fatty acid metabolism, assessed by VLDL measurements using leucine turnover technique.
Timepoint [2] 279827 0
Assessed after each 2 week intervention period, i.e. three times in women and twice in men.
Primary outcome [3] 279828 0
GH secretion, assessed by arginine stimulation test
Timepoint [3] 279828 0
Assessed after each 2 week intervention period, i.e. three times in women and twice in men.
Secondary outcome [1] 294524 0
Resting energy expenditure, assessed by indirect calorimetry
Timepoint [1] 294524 0
Assessed after each 2 week intervention period, i.e. three times in women and twice in men.
Secondary outcome [2] 294525 0
Fat oxidation, assessed by indirect calorimetry
Timepoint [2] 294525 0
Assessed after each 2 week intervention period, i.e. three times in women and twice in men.

Eligibility
Key inclusion criteria
Healthy postmenopausal women and men the same age
BMI <25 kg/m2
Minimum age
50 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of liver, kidney diseases, cancer, diabetes, endocrine disorders, that are likely to interfere with the metabolism or excretion of the test medication.

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)
The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents.
Allocation concealment - central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Only women will be randomized at study visit 1 after they have met the randomization criteria. At this visit the participant will be randomised (computer generated sequence) to study treatment with either oestrogen or tamoxifen. Letrozole treatment will always be given last to avoid any carry-over effects.
Men will always receive tamoxifen first, followed by letrozole treatment.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270071 0
Government body
Name [1] 270071 0
NHMRC
Address [1] 270071 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 270071 0
Australia
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
384 Victoria St
Darlinghurst 2010 NSW
Country
Australia
Secondary sponsor category [1] 269037 0
None
Name [1] 269037 0
Address [1] 269037 0
Country [1] 269037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272026 0
St Vincent's Hospital HREC
Ethics committee address [1] 272026 0
390 Victoria St
Darlinghurst 2010 NSW
Ethics committee country [1] 272026 0
Australia
Date submitted for ethics approval [1] 272026 0
22/06/2009
Approval date [1] 272026 0
09/07/2009
Ethics approval number [1] 272026 0
1/09/0090

Summary
Brief summary
The purpose of this study is to understand how oestrogen controls the use of fat in the liver. The hypothesis is that oestrogen is required to prevent the accumulation of fat in the liver. The mechanism may be direct or mediated by other hormones such as growth hormone, which is regulated by oestrogen.
We wish to study the effects of oestrogen compounds called Selective Oestrogen Receptor Modulators (tamoxifen) and a drug that prevents oestrogen production (letrozole) on the secretion of growth hormone from the special gland in brain and how they control the liver production and burning of fat in men and women. We wish to compare these effects with that of natural oestrogen itself in women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33288 0
Address 33288 0
Country 33288 0
Phone 33288 0
Fax 33288 0
Email 33288 0
Contact person for public queries
Name 16535 0
Vita Birzniece
Address 16535 0
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst 2010, NSW
Country 16535 0
Australia
Phone 16535 0
+61 2 92958483
Fax 16535 0
+61 2 92958481
Email 16535 0
v.birzniece@garvan.org.au
Contact person for scientific queries
Name 7463 0
Vita Birzniece
Address 7463 0
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst 2010, NSW
Country 7463 0
Australia
Phone 7463 0
+61 2 92958483
Fax 7463 0
+61 2 92958481
Email 7463 0
v.birzniece@garvan.org.au

No information has been provided regarding IPD availability
Summary results
No Results