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Women's International Study of long Duration Oestrogen after Menopause
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
  Email 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
  Email 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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