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

Insulin Resistance Clinical Trial

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 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02264743
Study type Interventional
Source Royal Brompton & Harefield NHS Foundation Trust
Contact John Stevenson, MBBS
Phone 0207 351 8112
Email j.stevenson@imperial.ac.uk
Status Recruiting
Phase Phase 4
Start date November 2013
Completion date November 2015
View Details
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