Ultra-low-dose oral E2/D will have more beneficial effects than trans-dermal HRT on lipids and insulin resistance in postmenopausal women, whilst adverse effects on coagulation will be avoided.
Following screening for eligibility, women will be studied at baseline and then randomized to one of two groups: Group A administered Femoston Conti - oral oestradiol 17β 0.5 mg/dydrogesterone 2.5 mg daily for the duration of the treatment phase (24 weeks) Group B administered ½ Evorel Conti patches - trans-dermal Estradiol 25 mcg/norethisterone acetate 85 mcg (½ Evorel Conti patches) daily for the duration of the treatment phase (24 weeks). Studies will be repeated after 6 months of therapy at the follow up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Ultra-low-dose oral E2/D \[Oestradiol 17β 0.5mg/dydrogesterone 2.5 mg\] oral Femoston Conti 0.5mg Estradiol\&Dydrogesterone vs Oestradiol\&Norethisterone acetate
Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom
RECRUITINGRoyal Brompton and Harefield NHS Trust
London, United Kingdom
RECRUITINGImperial College Healthcare NHS Trust
London, United Kingdom
RECRUITINGThrombin Generation IU/DL
Time frame: Six months
triglycerides
mmol/L
Time frame: 6 months
HDL
mmol/L
Time frame: 6 months
Total cholesterol
mmol/L
Time frame: 6 months
LDL
mmol/L
Time frame: 6 months
D-Dimers
ng/ml
Time frame: 6 months
APC resistance
\>2 or \<2
Time frame: 6 months
fibrinogen
g/L
Time frame: 6 months
Factor V11
U/ml
Time frame: 6 months
PAI-1 protein
nq/ml
Time frame: 6 months
fasting insulin
pmol/L
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
fasting glucose
mmol/L
Time frame: 6 months