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

Royal Brompton & Harefield NHS Foundation Trust

Status and phase: Unknown; Phase 4

Conditions: Insulin Resistance; Venous Thrombosis

Treatments: Drug: EVOREL® CONTI; Drug: Femoston Conti

Study type: Interventional

Funder types: Other

Identifiers

NCT02264743

2013MM002B

2013-002094-22 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Femoston Conti 0.5mg/2.5mg

Experimental group

Description:

Ultra low dose, film-coated 17β-estradiol (as hemihydrate) 0.5mg \& dydrogesterone 2.5 mg Once a day The duration is six months. Drug intervention: Estradiol\&DydrogesteronevsOestradiol\&Norethisterone acetate

Treatment:

Drug: Femoston Conti

EVOREL® CONTI transdermal patches

Active Comparator group

Description:

EVOREL CONTI is a transdermal self adhesive patch which is 0.1 mm in thickness and each patch releases 50mcg of oestradiol and 170mcg of norethisterone acetate over 24 hours . The Evorel Conti patch is cut in half and applied to the lower part of the body for 3.5 days (delivering approx 25mcg of oestradiol over 24 hours ) this is replaced every 3.5 days . The duration is six months. Drug intervention: Estradiol\&DydrogesteronevsOestradiol\&Norethisterone acetate

Treatment:

Drug: EVOREL® CONTI