Overview

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

Status:
Unknown status
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborators:
Chelsea and Westminster NHS Foundation Trust
Imperial College Healthcare NHS Trust
Treatments:
Dydrogesterone
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Norethindrone
Norethindrone acetate
Polyestradiol phosphate
Criteria
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