None listed
Conditions
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.
Interventions
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.
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy postmenopausal women and men the same age BMI <25 kg/m2
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.
Outcome results
None listed