Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
27/05/2010
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

Prof Stephen Killick

ORCID ID

Contact details

The Academic Department of Obstetrics & Gynaecology
Women and Children's
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
S.R.Killick@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084120683

Study information

Scientific title

Acronym

Study hypothesis

Is fibroid embolisation as effective as surgery in the treatment of anaemia due to menorrhagia caused by fibroids?

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Menorrhagia

Intervention

Please note that as of 27/05/10 the status of this trial was changed to "stopped" as the trial was never started.

Randomised controlled study

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. End point - one year post treatment or hysterectomy in the embolisation group
2. Outcome measures - Quality of life, haematocrit, length of hospital stay, time to return to work, patient satisfaction, complications, costs

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1999

Overall trial end date

28/02/2004

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

One hundred women with clinical anaemia due to menorrhagia caused by fibroids randomised to most appropriate surgery or embolisation.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/1999

Recruitment end date

28/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Academic Department of Obstetrics & Gynaecology
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research organisation

Funder name

The North and South Bank Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes