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