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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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

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Venous Thrombosis Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Femoston Conti 0.5mg/2.5mg

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

Group Type EXPERIMENTAL

Femoston Conti

Intervention Type DRUG

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

EVOREL® CONTI transdermal patches

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

Group Type ACTIVE_COMPARATOR

EVOREL® CONTI

Intervention Type DRUG

Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch

Interventions

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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

Intervention Type DRUG

EVOREL® CONTI

Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch

Intervention Type DRUG

Other Intervention Names

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Femoston Conti 0.5mg/2.5mg film-coated tablets versus Evorel Conti transdermal patch 25 mcg transdermal dose

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes