The effect of oestrogen replacement therapy taken either orally or transdermally and observing any likely benefit of both these therapies on the risks Venous thromobembolic events and cardiovascular heart disease. MedDRA version: 16.1 Level: HLGT Classification code 10027309 Term: Menopause and related conditions System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Femoston-conti
Pharmaceutical Form: Film-coated tablet
Trade Name: EVOREL® CONTI
Pharmaceutical Form: Transdermal patch
Sponsors
Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Healthy and postmenopausal woman who have had a normal ultrasound result during the study screening visit (or obtained during routine clinical care and within 6 weeks of the visit taking place). ? aged 40 - 60 years ? at least 1 year post last menstrual period (per participant report) ? BMI 18 - 32 ? Verbal confirmation of a normal mammogram within 2 years of study commencement ? continue on any concomitant medications without any change during the study ? give informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, anti-androgens, PDE5 inhibitors, DHEA, SERMS) • have a significant psychiatric disorder • have a history of breast cancer • have diabetes, thrombo-embolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the cardiovascular system differences regarding insulin resistance, lipids/lipoproteins and fibrinolysis in each of the groups (oral versus trans-dermal HRT). ;Primary end point(s): Thrombin generation will be the primary endpoint. Thrombin is a serine protease: enzymes that cleave peptide bonds in proteins that in humans is encoded by the F2 gene. Prothrombin (coagulation factor II) is proteolytically cleaved to form thrombin in the coagulation cascade, Thrombin in turn acts as a serine protease that converts soluble fibrinogen into insoluble strands of fibrin, as well as catalyzing many other coagulation-related reactions. Measurement of time to peak thrombin generation has been shown to be a useful marker for coagulation activation. ;Timepoint(s) of evaluation of this end point: It will be measured at the start and at the end of the study, and analysed as a continuous variable. ;Main Objective: To assess the cardiovascular system differences regarding coagulation activation(oral versus trans-dermal HRT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Insulin resistance will be calculated from the fasting plasma glucose and insulin values using the established HOMA equation. - Total cholesterol, triglycerides and HDL cholesterol are measured directly and LDL cholesterol is ccalculated using the Friedwald formula. - Fibrin, D-dimers, activated protein C (APC) resistance, fibrinogen, factor VII. antithrombin and plasminogen activator inhibitor-1 (PAI-1) are measured directly as further markers of coagulation activation, fibrinolysis and susceptibility to venous thrombosis. ;Timepoint(s) of evaluation of this end point: These will be measured at the start and at the end of the study, and analysed as continuous variables. | — |
Countries
United Kingdom
Contacts
Public ContactIra Jakupovic
Royal Brompton and Harefield NHS Foundation Trust
Outcome results
None listed