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

Insulin Resistance Clinical Trial

— OPTIMISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264743
• Other study ID #: 2013MM002B
• Secondary ID: 2013-002094-22
• Status: Recruiting
• Phase: Phase 4
• First received: December 20, 2013
• Last updated: October 14, 2014
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2014
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: John Stevenson, MBBS
• Phone: 0207 351 8112
• Email: j.stevenson[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Venous Thrombosis

Intervention

Drug:
• Femoston Conti
Ultra-low-dose oral E2/D [Oestradiol 17ß 0.5mg/dydrogesterone 2.5 mg] oral Femoston Conti 0.5mg Estradiol&Dydrogesterone vs Oestradiol&Norethisterone acetate
• EVOREL® CONTI
Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Royal Brompton and Harefield NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Chelsea and Westminster NHS Foundation Trust, Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin Generation IU/DL		Six months	No
Secondary	triglycerides	mmol/L	6 months	No
Secondary	HDL	mmol/L	6 months	No
Secondary	Total cholesterol	mmol/L	6 months	No
Secondary	LDL	mmol/L	6 months	No
Secondary	D-Dimers	ng/ml	6 months	No
Secondary	APC resistance	>2 or <2	6 months	No
Secondary	fibrinogen	g/L	6 months	No
Secondary	Factor V11	U/ml	6 months	No
Secondary	PAI-1 protein	nq/ml	6 months	No
Secondary	fasting insulin	pmol/L	6 months	No
Secondary	fasting glucose	mmol/L	6 months	No