Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy
- Conditions
- Venous ThrombosisInsulin Resistance
- Interventions
- Drug: Femoston ContiDrug: EVOREL® CONTI
- Registration Number
- NCT02264743
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Femoston Conti 0.5mg/2.5mg Femoston Conti Ultra low dose, film-coated 17β-estradiol (as hemihydrate) 0.5mg \& dydrogesterone 2.5 mg Once a day The duration is six months. Drug intervention: Estradiol\&DydrogesteronevsOestradiol\&Norethisterone acetate EVOREL® CONTI transdermal patches EVOREL® CONTI EVOREL CONTI is a transdermal self adhesive patch which is 0.1 mm in thickness and each patch releases 50mcg of oestradiol and 170mcg of norethisterone acetate over 24 hours . The Evorel Conti patch is cut in half and applied to the lower part of the body for 3.5 days (delivering approx 25mcg of oestradiol over 24 hours ) this is replaced every 3.5 days . The duration is six months. Drug intervention: Estradiol\&DydrogesteronevsOestradiol\&Norethisterone acetate
- Primary Outcome Measures
Name Time Method Thrombin Generation IU/DL Six months
- Secondary Outcome Measures
Name Time Method Factor V11 6 months U/ml
triglycerides 6 months mmol/L
LDL 6 months mmol/L
D-Dimers 6 months ng/ml
fasting glucose 6 months mmol/L
Total cholesterol 6 months mmol/L
APC resistance 6 months \>2 or \<2
fasting insulin 6 months pmol/L
HDL 6 months mmol/L
fibrinogen 6 months g/L
PAI-1 protein 6 months nq/ml
Trial Locations
- Locations (3)
Chelsea and Westminster NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Brompton and Harefield NHS Trust
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom