Insulin Resistance, Venous Thrombosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFemoston Conti
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
DRUGEVOREL® CONTI
Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch
Sponsors
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy and postmenopausal woman who have had a normal ultrasound result * Aged 40 - 60 years * At least 1 year post last menstrual period (per participant report) * BMI 18 - 32 * Normal mammogram within 2 years of study commencement * Continue on any concomitant medications without any change during the study give informed consent
Exclusion criteria
* Estrogen or androgen therapy during preceding 3 months * Use of hormone implants during the preceding 12 months * Have received any medications which may interfere with the study (SSRI, antiandrogens, * PDE5 inhibitors, DHEA, SERMS) * Have a significant psychiatric disorder * Have a history of breast or oestrogen dependent cancer * Have diabetes, thrombo-embolic disorders (recent MI angina DVT varicose veins or recurrent DVT), cardiovascular disease, liver disease any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia * Untreated endometrial hyperplasia * Dubin-Johnson syndrome and Rotor syndrome * Undiagnosed vaginal bleeding * Women who have had a hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombin Generation IU/DL | Six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL | 6 months | mmol/L |
| D-Dimers | 6 months | ng/ml |
| APC resistance | 6 months | \>2 or \<2 |
| fibrinogen | 6 months | g/L |
| Factor V11 | 6 months | U/ml |
| Total cholesterol | 6 months | mmol/L |
| fasting insulin | 6 months | pmol/L |
| triglycerides | 6 months | mmol/L |
| HDL | 6 months | mmol/L |
| fasting glucose | 6 months | mmol/L |
| PAI-1 protein | 6 months | nq/ml |
Countries
United Kingdom
Contacts
Primary ContactJohn Stevenson, MBBS
Backup ContactMarie Gerval, MBBS
Outcome results
None listed