A multi-centre randomised controlled trial assessing the costs and benefits of using structured information and analysis of women's preferences in the management of menorrhagia

Not Applicable

Completed

• Conditions: rological and genital diseases: Menstrual disorders; Urological and Genital Diseases; Menorrhagia

• Registration Number: ISRCTN85619876
• Lead Sponsor: Department of Health (UK)

Brief Summary

2003 Results article in https://doi.org/10.3310/hta7080 HTA monograph

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2000-08-31
• Study Start: 2003-04-25
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Women with menorrhagia

Exclusion Criteria

Not provided at time of registration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.