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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85619876

Enrollment

200

Registered

2003-04-25

Start date

1995-10-01

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and genital diseases: Menstrual disorders Urological and Genital Diseases Menorrhagia

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women with menorrhagia

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026