%0 Journal Article
%T The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial
%A Madge R Vickers
%A Jeannett Martin
%A Tom W Meade
%A the WISDOM study team
%J BMC Women's Health
%D 2007
%I BioMed Central
%R 10.1186/1472-6874-7-2
%X Randomised, placebo, controlled, trial.The trial was set in general practices in the UK (384), Australia (94), and New Zealand (24). In these practices 284175 women aged 50¨C69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 ¨C 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease.The trial was prematurely closed during recruitment following publication of early results from the Women's Health Initiative. At the time of closure, 56583 had been screened, 8980 entered run-in, and 5694 (26% of target of 22,300) randomised. Those women randomised had received a mean of one year of therapy, mean age was 62.8 years and total follow-up time was 6491 person years.The WISDOM experience leads to some simple messages. The larger a trial is the more simple it needs to be to ensure cost effective and timely delivery. When a trial is very costly and beyond the resources of one country, funders and investigators should make every effort to develop international collaboration with joint funding.The Women's International Study of long Duration Oestrogen after Menopause (WISDOM) developed from a joint initiative of the UK Medical Research Council (MRC) and the UK Departments of Health. At the start of the WISDOM trial observational studies had suggested that long term use of estrogen was likely to be associated with a reduced risk of osteoporosis [1] and ischaemic heart disease (IHD) [2] and an increased risk of breast cancer [3] and endometrial cancer [4]. While concomitant use of progestogens could protect against endometrial cancer [4], it was not cl
%U http://www.biomedcentral.com/1472-6874/7/2