Condition category
Urological and Genital Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Kennedy

ORCID ID

Contact details

Council on Health Research for Development
11 Rue de Cornavin
Geneva
CH-1201
Switzerland
+41 591 8900
kennedy@cohred.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/18/12

Study information

Scientific title

Acronym

Study hypothesis

Each of the medical and surgical therapies available for the treatment of menorrhagia has different outcomes, risks and benefits. Women are likely to have different attitudes towards the trade-offs that present themselves when choosing a treatment. It is important, therefore, that women's preferences are taken into account when treatment decisions are being made. However, in order to share in decision making, women need structured and full information on menorrhagia and its treatment.

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

Urological and genital diseases: Menstrual disorders

Intervention

Randomised controlled trial. This study is made up of two phases. Phase I will involve developing structured information on menorrhagia in the form of a booklet and a video, together with an interview protocol to be used to assess women's preferences regarding the treatment of the condition. In Phase II, 600 women with menorrhagia referred to one of five hospitals will be randomised to standard management or to a new management strategy involving the provision of structured information and the assessment of preferences using the package developed in Phase I. Women will be followed-up over 2 years to assess the effectiveness and cost-effectiveness of the new management strategy. The extensive data collected in Phase II of the study will facilitate secondary analyses that will provide information to improve the effectiveness and cost-effectiveness of the management of menorrhagia.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Women will be followed-up over 2 years to assess the effectiveness and cost-effectiveness of the new management strategy. The primary outcome was health status, measured using the 36-item short-form general health survey (SF-36) instrument.

Secondary outcome measures

Secondary outcomes included women's treatment preferences, treatments undergone and satisfaction. In the economic analyses, health outcomes were measured in terms of quality-adjusted life-years (QALYs) based on women's responses to the EQ-5D (EuroQol-5 dimensions) instrument.

Overall trial start date

01/10/1995

Overall trial end date

31/08/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Women with menorrhagia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/10/1995

Recruitment end date

31/08/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Council on Health Research for Development
Geneva
CH-1201
Switzerland

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/12633525

Publication citations

  1. HTA monograph

    Kennedy AD, Sculpher MJ, Coulter A, Dwyer N, Rees M, Horsley S, Cowley D, Kidson C, Kirwin C, Naish C, Bidgood K, Cullimore J, Kerr-Wilson R, Abrams KR, Stirrat G, A multicentre randomised controlled trial assessing the costs and benefits of using structured information and analysis of women's preferences in the management of menorrhagia., Health Technol Assess, 2003, 7, 8, 1-76.

Additional files

Editorial Notes