Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
20/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Madge Vickers

ORCID ID

Contact details

MRC Epidemiology and Medical Care Unit
Northwick Park Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom
+44 (0)20 8864 3232
madge.vickers@ntlworld.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

E185/126

Study information

Scientific title

Acronym

WISDOM

Study hypothesis

To establish the balance between benefits and risks of long-term hormone replacement therapy, HRT, in post-menopausal women.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Fatal and non-fatal ischaemic heart disease and unstable angina, major osteoporotic fractures, breast cancer.

Secondary outcome measures

Cancers, stroke, deep vein thrombosis deaths, quality of life, cost effectiveness plus other conditions possibly affected by HRT.

Overall trial start date

01/10/1999

Overall trial end date

30/09/2016

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Postmenopausal women aged 50-69 years

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

34,000 - 22,000 from the UK. Recruitment suspended 17/10/02.

Participant 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)

Recruitment start date

01/10/1999

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Australia, New Zealand, United Kingdom

Trial participating centre

MRC Epidemiology and Medical Care Unit
Harrow Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: E185/126)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

British Heart Foundation (UK) (ref: RG/94006)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Welton A, Hepworth J, Collins N, Ford D, Knott C, Meredith S, Walgrove A, Wilkes H, Vickers M, , Decision-making about hormone replacement therapy by women in England and Scotland., Climacteric, 2004, 7, 1, 41-49.

  2. Vickers MR, Martin J, Meade TW, , The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial., BMC Womens Health, 2007, 7, 2, doi: 10.1186/1472-6874-7-2.

  3. Vickers MR, MacLennan AH, Lawton B, Ford D, Martin J, Meredith SK, DeStavola BL, Rose S, Dowell A, Wilkes HC, Darbyshire JH, Meade TW, , Main morbidities recorded in the women's international study of long duration oestrogen after menopause (WISDOM): a randomised controlled trial of hormone replacement therapy in postmenopausal women., BMJ, 2007, 335, 7613, 239, doi: 10.1136/bmj.39266.425069.AD.

  4. Welton AJ, Vickers MR, Kim J, Ford D, Lawton BA, MacLennan AH, Meredith SK, Martin J, Meade TW, , Health related quality of life after combined hormone replacement therapy: randomised controlled trial., BMJ, 2008, 337, a1190.

Additional files

Editorial Notes