Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002094-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chelsea and Westminster NHS Foundation Trust | OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoston Conti 0.5mg/2.5mg | Experimental | 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 |
|
| EVORELĀ® CONTI transdermal patches | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoston Conti | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin Generation IU/DL | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| triglycerides | mmol/L | 6 months |
| HDL | mmol/L | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Stevenson, MBBS | Contact | 0207 351 8112 | j.stevenson@imperial.ac.uk | |
| Marie Gerval, MBBS | Contact | 07734386042 | m.gerval@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| John Stevenson, MBBS | Royal Brompton & Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster NHS Foundation Trust | Recruiting | London | SW10 9NH | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| EVORELĀ® CONTI | Drug | Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch |
|
|
| Total cholesterol |
mmol/L |
| 6 months |
| LDL | mmol/L | 6 months |
| D-Dimers | ng/ml | 6 months |
| APC resistance | >2 or <2 | 6 months |
| fibrinogen | g/L | 6 months |
| Factor V11 | U/ml | 6 months |
| PAI-1 protein | nq/ml | 6 months |
| fasting insulin | pmol/L | 6 months |
| fasting glucose | mmol/L | 6 months |
| Royal Brompton and Harefield NHS Trust | Recruiting | London | SW3 6NP | United Kingdom |
|
| Imperial College Healthcare NHS Trust | Recruiting | London | W12 0HS | United Kingdom |
|
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |