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ISRCTN
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ISRCTN86566246
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DOI
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10.1186/ISRCTN86566246
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia
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Scientific title
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Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia: a randomised controlled trial
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Acronym
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ECLIPSE
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Serial number at source
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HTA 02/06/02
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Study hypothesis
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Menorrhagia is a very common problem affecting women’s lives. Attendant demand on time and resources in primary and secondary care is considerable. However it is unclear which treatment options are the most effective and the most acceptable to women, particularly in the long term, and experience of care varies widely. Currently 1 in 5 women in the UK have a hysterectomy, half of whom present with heavy periods. This trial will assess the effectiveness, cost effectiveness and acceptability of using the levonorgestrel IUS (Mirena coil) compared to standard medical treatment for women with menorrhagia presenting in primary care.
Please note that, as of 17/01/2008, the anticipated start and end dates of this trial have been updated from 01/01/2004 and 31/08/2012 to 01/11/2004 and 30/06/2013, respectively.
Please note that, as of 30/01/2009, extensive amendments have been made to this ISRCTN record, including the following:
1. Scientific title was added
2. Target number of participants was amended from 1,000 to 570
Other amendments are recorded within the relevant fields.
Please note that, as of 04/09/2009, the anticipated end date of this trail has been updated from 30/06/2013 to 31/12/2014.
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Lay summary
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Not provided at time of registration
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Ethics approval
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South West Research Ethics Committee, approved on 18/08/2004 (ref: 04/MRE06/7). The latest approval for amendments was given on 25/07/2008.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Menorrhagia
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Participants - inclusion criteria
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Women between the ages of 25-50 presenting to General Practitioners with menorrhagia, who are not intending to become pregnant in the next 5 years
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Participants - exclusion criteria
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1. Taking HRT
2. Patients with any contraindications to an IUS, with or without Levonorgestrel
3. Patients with contraindications to medical therapy
4. Women with abdominally palpable enlarged fibroid uteri (10-12 Weeks size)
5. Women to whom the contraceptive effect of LNG-IUS would be unacceptable.
6. Women with symptoms suggestive of other pathology (irregular bleeding, intermenstrual bleeding, postcoital bleeding)
7. Women with risk factors for endometrial cancer (tamoxifen treatment, unopposed ostrogen treatments)
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/12/2014
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Status of trial
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Ongoing |
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Patient information material
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Patient information can be found at: http://www.eclipse.bham.ac.uk/documents/Eclipse_PIS_v1.1_dated_21.07.08.pdf
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Target number of participants
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570
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Interventions
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Levonorgestrel-releasing intrauterine systems compared with standard medical treatment, based on the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines
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Primary outcome measure(s)
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Added as of 30/01/2009:
The Shaw Menorrhagia Questionnaire
All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years.
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Secondary outcome measure(s)
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Added as of 30/01/2009:
1. SF-36® Health Survey
2. Sexual Activity Questionnaire
3. Euroqol EQ-5D
All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.eclipse.bham.ac.uk/
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Publications
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1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23301731
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Contact name
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Prof
Janesh
Gupta
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Address
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Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TG
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Country
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United Kingdom
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Tel
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+44 (0)121 607 4751
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Fax
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+44 (0)121 607 4795
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Email
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j.k.gupta@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Sponsor website:
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http://www.bham.ac.uk/
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Date applied
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10/06/2004
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Last edited
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11/01/2013
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Date ISRCTN assigned
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11/06/2004
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