Women's International Study of long Duration Oestrogen after Menopause

ISRCTN	ISRCTN63718836
DOI	https://doi.org/10.1186/ISRCTN63718836
Protocol serial number	E185/126
Sponsor	Medical Research Council (MRC) (UK)
Funders	Medical Research Council (UK) (ref: E185/126), British Heart Foundation (UK) (ref: RG/94006)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Madge Vickers
Scientific

MRC Epidemiology and Medical Care Unit
Northwick Park Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom

Phone	+44 (0)20 8864 3232
Email	madge.vickers@ntlworld.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Women's International Study of long Duration Oestrogen after Menopause
Study acronym	WISDOM
Study objectives	To establish the balance between benefits and risks of long-term hormone replacement therapy, HRT, in post-menopausal women.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obstetrics and gynaecology
Intervention	Long-term hormone replacement therapy vs placebo. Stopped in 2002 after similar study showed risks to patients (reported by the BBC)
Intervention type	Other
Primary outcome measure(s)	Fatal and non-fatal ischaemic heart disease and unstable angina, major osteoporotic fractures, breast cancer.
Key secondary outcome measure(s)	Cancers, stroke, deep vein thrombosis deaths, quality of life, cost effectiveness plus other conditions possibly affected by HRT.
Completion date	30/09/2016
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	34000
Key inclusion criteria	Postmenopausal women aged 50-69 years
Key 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)
Date of first enrolment	01/10/1999
Date of final enrolment	30/09/2016

MRC Epidemiology and Medical Care Unit

Harrow Middlesex
HA1 3UJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article		01/03/2004	Yes	No
Results article		26/02/2007	Yes	No
Other publications	Main morbidities recorded	04/08/2007	Yes	No
Other publications	Health related quality of life results	21/08/2008	Yes	No

07/11/2022: Internal review.