| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN63718836 |
| Date ISRCTN assigned | 25/10/2000 |
| Local reference number(s) | E185/126 |
| Public title | Women's International Study of long Duration Oestrogen after Menopause |
| Scientific title |
|
| Acronym | WISDOM |
| Disease/condition/study domain | Obstetrics and gynaecology |
| Study hypothesis | To establish the balance between benefits and risks of long-term hormone replacement therapy, HRT, in post-menopausal women. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom, Australia, New Zealand |
| Participants - inclusion criteria | Postmenopausal women aged 50-69 years |
| Participants - 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). |
| Patient information material |
|
| Anticipated start date | 01/10/1999 |
| Anticipated end date | 30/09/2016 |
| Status of trial | Stopped |
| Target number of participants | 34,000 - 22,000 from the UK. Recruitment suspended 17/10/02 |
| Interventions | Long-term hormone replacement therapy/placebo |
| Primary outcome measure(s) | Fatal and non-fatal ischaemic heart disease and unstable angina, major osteoporotic fractures, breast cancer. |
| Secondary outcome measure(s) | Cancers, stroke, deep vein thrombosis deaths, quality of life, cost effectiveness plus other conditions possibly affected by HRT. |
| Publications | Results in:
1. 2004: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=15259282
2. 2007: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17324282
3. 2007: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17626056 |
| Sources of funding | 1. Medical Research Council (UK) (ref: E185/126)
2. British Heart Foundation (UK) (ref: RG/94006) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr Madge Vickers |
| Contact details | MRC Epidemiology and Medical Care Unit
Northwick Park Hospital
Watford Road
Harrow Middlesex
United Kingdom
HA1 3UJ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN63718836 |
| Date last extracted from ISRCTN register | 17/04/2008 |
