Obstetrics and gynaecology Urological and Genital Diseases Post-menopause
Conditions
Interventions
Women who have had a hysterectomy and are not already taking HRT will be randomised to oestrogen only replacement therapy (ORT), progestogen and oestrogen replacement therapy (PORT) or placebo.
Women
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Age 50-69, female, post-menopausal, no contraindication to HRT. For both components, in addition to the WISDOM trial inclusion criteria, subjects will only be recruited if they can be randomised to receive placebo, ie excluding the 21% of WISDOM recruits with a total hysterectomy who are already taking HRT. For the dementia component sub-study only those who will reach the age of 65 years before the end of the projected follow-up period (2009) will be included.
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dementia component: The principal outcome will be onset of dementia according to ICD-10 criteria. Cognitive component: Change of cognitive test performance on the Wechsler Logical Memory Recall. The trial will have 90% power, at the 5% significance level, to detect an effect size, associated with randomisation to HRT, of 0.5 or greater enabling us to detect a difference of two story components recalled out of a total of 25 for Wechsler Logical Memory story recall. Added 19/08/09: Follow up duration for primary endpoints Dementia component - 2009 (10 years) Cognitive component - Five years | — |
Secondary
| Measure | Time frame |
|---|---|
| Dementia component: The secondary outcome will be onset of the dementia sub-type diagnosis of Alzheimer's disease (AD) diagnosed according to NINCDS-ADRDA criteria (possible and probable). | — |
Countries
United Kingdom
Outcome results
None listed