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Clinical Trial Details

The neuroendocrine and metabolic effects of oestrogens

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Trial Information

Broad Health Condition Metabolic and Endocrine

Specific Health ConditionNormal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/08/2010

Anticipated date of last participant enrolment3/08/2010

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

Key inclusion criteria

Healthy postmenopausal women and men the same age
BMI <25 kg/m2

Minimum age50 Years

Maximum age70 Years

GenderBoth 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.
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Primary Sponsor Address: 384 Victoria St Darlinghurst 2010 NSW
Primary Sponsor Country: Australia

Trial IDACTRN12611001093976

Contact person for information and recruitment
Vita Birzniece
Garvan Institute of Medical Research 384 Victoria St Darlinghurst 2010, NSW
+61 2 92958483
+61 2 92958481
Further information iconv.birzniece@garvan.org.au
Australia