Randomised controlled trial of LNG-IUS (coil) against standard treatment (medical management) for patients suffering with Heavy Menstrual Bleeding

Phase 1

• Conditions: Menorrhagia; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2004-001552-37-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-08
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 570

Inclusion Criteria

Women between the ages of 25-50 presenting to General Practitioners with menorrhagia (see Section 3.2 of protocol for specific definition).
Not intending to become pregnant in the next 5 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 570
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women taking HRT
Women with contraindications to IUD use, with or without Levonorgestrel
Women with contraindications to all medical treatments for menorrhagia
Women with abdominally palpable enlarged fibroid uteri (10-12 weeks size)
Women to whom the contraceptive effect of LNG-IUS would be unacceptable
Women with symptoms suggestive of other pathology:
Women with risk factors for endometrial cancer:

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The ECLIPSE Trial is a large, pragmatic, real-life” community based trial that will determine reliably whether a (Levonorgestrel-releasing intrauterine system) LNG-IUS is preferable to standard medical treatments (i.e. tranexamic acid, mefenamic acid or contraceptive pill as per Royal College of Obstetrics and Gynaecology guidelines) for menorrhagia;Secondary Objective: The cost-effectiveness and acceptability of treatment policies.;Primary end point(s): The Shaw Menorrhagia Questionnaire is the primary outcome measure. Menorrhagia is a subjective problem and quality of life is affected by practical difficulties and the impact on social life, psychological wellbeing, physical health, work routine and family life. The Shaw questionnaire attempts to capture the consequences of menorrhagia on these domains with 6 questions each with 4 levels of response.<br>;Timepoint(s) of evaluation of this end point: Baseline, 6months, 1year, 2year and 5year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Short Form-36<br>The SF-36 v2 is a 36-item short-form survey that measures general health-related quality of life (HRQOL) and can be used to obtain utilities.39 The SF-36 is a practical and reliable way to obtain important health outcomes data in a variety of settings, measuring eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health. The standard format with 4-week recall period will be used to capture the average quality of life over a menstrual cycle.;Timepoint(s) of evaluation of this end point: Baseline, 6months, 1year, 2year and 5year