Obstetrics and gynaecology Urological and Genital Diseases
Conditions
Interventions
Long-term hormone replacement therapy vs placebo. Stopped in 2002 after similar study showed risks to patients (reported by the BBC)
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Postmenopausal women aged 50-69 years
Exclusion criteria
Exclusion criteria: 1. Premenopausal 2. History of endometriosis or endometrial hyperplasia in women with a uterus 3. Breast cancer 4. BrCa 1 and 2 carriers 5. Melanoma ever 6. Invasive cancer within 10 years (except basal and squamous cell carcinoma) 7. Meningioma 8. Currently active liver disease 9. Severe renal impairment 10. Gall bladder disease unless cholescystectomy 11. DVT, PE, RVO 12. Otosclerosis 13. Porphyria, history of hepatitis B or HIV 14. Fasting triglyceride greater than 5.5 millimoles per litre; current treatment with selective oestrogen receptor modulators (e.g. tamoxifen)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Cancers, stroke, deep vein thrombosis deaths, quality of life, cost effectiveness plus other conditions possibly affected by HRT. | — |
Primary
| Measure | Time frame |
|---|---|
| Fatal and non-fatal ischaemic heart disease and unstable angina, major osteoporotic fractures, breast cancer. | — |
Countries
Australia, England, New Zealand, United Kingdom
Outcome results
None listed