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21 March 2013
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| Women's International Study of long Duration Oestrogen after Menopause |
| ISRCTN | ISRCTN63718836 |
| DOI | 10.1186/ISRCTN63718836 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Women's International Study of long Duration Oestrogen after Menopause |
| Scientific title | |
| Acronym | WISDOM |
| Serial number at source | E185/126 |
| Study hypothesis | To establish the balance between benefits and risks of long-term hormone replacement therapy, HRT, in post-menopausal women. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Australia, New Zealand, United Kingdom |
| Disease/condition/study domain | Obstetrics and gynaecology |
| 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) |
| Anticipated start date | 01/10/1999 |
| Anticipated end date | 30/09/2016 |
| Status of trial | Stopped |
| Patient information material | |
| Target number of participants | 34,000 - 22,000 from the UK. Recruitment suspended 17/10/02. |
| Interventions | Long-term hormone replacement therapy vs placebo. Stopped in 2002 after similar study showed risks to patients (reported by the BBC) |
| 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. |
| Sources of funding |
1. Medical Research Council (UK) (ref: E185/126)
2. British Heart Foundation (UK) (ref: RG/94006) |
| Trial website | |
| Publications |
Results in:
1. 2004: http://www.ncbi.nlm.nih.gov/pubmed/15259282 2. 2007: http://www.ncbi.nlm.nih.gov/pubmed/17324282 3. 2007: http://www.ncbi.nlm.nih.gov/pubmed/17626056 4. 2008: http://www.ncbi.nlm.nih.gov/pubmed/18719013 |
| Contact name | Dr Madge Vickers |
| Address |
MRC Epidemiology and Medical Care Unit
Northwick Park Hospital Watford Road |
| City/town | Harrow Middlesex |
| Zip/Postcode | HA1 3UJ |
| Country | United Kingdom |
| Tel | +44 (0)20 8864 3232 |
| madge.vickers@ntlworld.com | |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 25/10/2000 |
| Last edited | 20/10/2010 |
| Date ISRCTN assigned | 25/10/2000 |
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