Details of HTA project in progress
Last updated: 21 May 2013 - Next update due: 28 May 2013
Research type: |
Primary Research (e.g. trial) |
Project title: |
Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard trEatment - The ECLIPSE Trial |
 Outputs in journals arising from this project
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Project ref: |
02/06/02 |
Cost: |
£1,450,230 |
Chief Investigator : |
Professor Janesh Kumar Gupta, Professor of Obstetrics and Gynaecology, Academic Department of Obstetrics and Gynaecology, University of Birmingham |
Project Website |
http://www.eclipse.bham.ac.uk |
Project Email |
eclipse@bham.ac.uk |
Start Date: |
November 2004 |
Estimated date of publication in HTA journal series: |
Late 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Heavy periods (menorrhagia) is a very common problem affecting women's lives. The impact of this condition has considerable demand on time and resources in primary and secondary care. 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. We want to involve around 120 general practices each recruiting 4 to 5 women with menorrhagia per year to the trial. We wish to recruit around 1200 patients over a two to three year period, commencing November 2004. We will then follow up women, by questionnaire over several years, to look at outcomes such as menorrhagia, quality of life, specialist referrals, duration of treatment, surgical interventions and patient safety. |
Project Abstract: |
1. Previous trials show that Mirena is more effective than standard medical treatment in reducing the amount of menstrual blood loss in the short term but have not addressed quality of life or longer-term outcomes. We, therefore, propose a RCT, by intention to treat, to evaluate the effects of Mirena versus standard medical treatment (based on RCOG guidelines) over the longer term and in the primary care setting. 2. The project will measure patient centred and surgical outcomes over the "patient journey" along with resource use, in primary and secondary care, over time. 3. The project will model the utilisation and costs of the different intended treatments on the basis of these data. We will thereby be able to confirm, or refute, the hypothesis that treatment of menorrhagia with Mirena in primary care results in gain for patient and health services in the short and long-term compared to standard medical treatment. 4. Extensive sensitivity analysis will be conducted to explore the robustness of the results to the assumptions made. The use of a modelling approach provides the flexibility to readily incorporate new data within the existing analysis as such data become available. |
MeSH* index primary terms: |
INTRAUTERINE-DEVICES-MEDICATED Q-economics; LEVONORGESTREL Q-administration-&-dosage; CONTRACEPTIVES-ORAL Q-administration-&-dosage |
MeSH* index secondary terms: |
HUMAN; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; QUALITY-OF-LIFE; LEVONORGESTREL Q-economics; CONTRACEPTIVES-ORAL Q-economics; COST-BENEFIT-ANALYSIS; FEMALE; ADULT; MIDDLE-AGED; AGED |
NRR* number, if applicable: |
N0484128014 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 86566246 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN86566246 |
Project Protocol: |
Project protocol (pdf format, 684 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1374 |
Outputs from this project
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