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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


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
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