Status:
UNKNOWN
Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
Conditions:
Venous Thrombosis
Insulin Resistance
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02264743
Start Date
November 1 2013
End Date
November 1 2015
Last Update
October 15 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom, SW10 9NH
2
Royal Brompton and Harefield NHS Trust
London, United Kingdom, SW3 6NP
3
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS