Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy

Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease

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.

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