Clinical trial NCT02264743: Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy
Official title: Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Venous Thrombosis
Insulin Resistance
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Chelsea and Westminster NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
First posted: 2014-10-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thrombin Generation IU/DL
timeFrame: Six months
Secondary outcomes:
measure: triglycerides
timeFrame: 6 months
measure: HDL
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: LDL
timeFrame: 6 months
measure: D-Dimers
timeFrame: 6 months
measure: APC resistance
timeFrame: 6 months
measure: fibrinogen
timeFrame: 6 months
measure: Factor V11
timeFrame: 6 months
measure: PAI-1 protein
timeFrame: 6 months
measure: fasting insulin
timeFrame: 6 months
measure: fasting glucose
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: John Stevenson, MBBS
role: PRINCIPAL_INVESTIGATOR
References: