NCT02264743

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Venous Thrombosis
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Femoston Conti	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
DRUG	EVOREL® CONTI	Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-11-01
• Completion: 2015-11-01
• First posted: 2014-10-15
• Last updated: 2014-10-15

Locations

3 sites across 1 country: United Kingdom