ECLIPSE Trial. Mirena IUS vs other medical treatment options for heavy menstrual bleeding: A RCT

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1 ECLIPSE Trial Mirena IUS vs other medical treatment options for heavy menstrual bleeding: A RCT Professor Janesh Gupta Senior Lecturer / Honorary Clinical Consultant University of Birmingham Birmingham Women s Hospital Professor Joe Kai University of Nottingham Graduate Medical School, Derby

2 Heavy Periods Affects up to 30% of women of reproductive age 12% result in secondary care referrals with up to 50% surgical intervention rate Two thirds result in hysterectomies and endometrial ablations 50% of hysterectomies are normal uteri

3 Number of hysterectomies for menorrhagia from to in NHS trusts in England Reid, P. C et al. BMJ 2005;330: Copyright 2005 BMJ Publishing Group Ltd.

4 Hospital Episodes Statistics (HES) in NHS Hospitals in England Number of procedures Total All hysterectomies Endometrial ablation

5 Schematic of RCT evidence on medical versus surgical interventions Heavy menstrual bleeding: NICE Guideline January 2007

6 ECLIPSE TRIAL Effectiveness and Cost effectiveness of Levonorgestrel containing Intrauterine system (LNG-IUS) in Primary Care against Standard Treatment for menorrhagia RCT trial design in primary care Recruitment completed with 571 patients NIHR HTA Funding 1.6 million - 5 years

7 Levonorgestrel (Mirena) IUS Device versus usual medical treatment: tranexamic acid, mefenamic acid, combined contraception or progestogens

8 Milestones August / September MREC AND MHRA Approvals February 2005 First patient randomised into Eclipse February 2006 Study is threatened with closure due to poor recruitment February 2006 Amendment approved to introduce secondary care clinics January NICE Guideline CG44 Heavy Menstrual Bleeding March NIHR HTA highlight the Institute s support for the completion of the Eclipse study and the usefulness of the results in updating the NICE guideline April 2007 Revised sample size from 1200 to 570 July Qualitative study Medical treatments for heavy menstrual bleeding: Understanding women s experiences

9 Milestones September month extension accepted by NIHR HTA July 2009 Recruitment ended with 571 patients August Case note review commenced July Shaw short paper has been accepted by BJOG and published online July 2011 All patients completed 2yr follow-up July Sub-study to Eclipse Measuring benefit of treatment in heavy menstrual bleeding for economic evaluations: Which instrument is most appropriate January Eclipse published July All women will have 5 year minimum follow-up December 2014 Current end date Complete analyses and publish results of final (5-year) clinical and cost effectiveness.

10 ECLIPSE ECLIPSE is a long-term trial with initial 24-month follow-up 5-year follow-up is intended 10-year follow-up is planned Primary care setting is real life

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12 Current Follow-up Baseline 99% 6 Month 84% 12 Month 87% Two years 96% Five years 85%

13 Results 571 women from 63 UK Centres Feb Jul % (215/286) of usual medical treatment group used mefenamic acid, tranexamic acid or their combination

14 Results of primary outcome: Menorrhagia Multi-Attribute Scale (MMAS) overall score Excluding women who crossed over between treatment groups increased the treatment benefit of LNG-IUS over usual medical treatment to 17.8 points (95% CI, 14.1 to 21.5 points; p<0.001)

15 Results of Quality of Life and Sexual Activity Questionnaires

16 Time to first treatment change (cross-over or stop treatment) to two years Reasons for changing treatment Lack of effectiveness Irregular / prolonged bleeding LNG-IUS 37% (29/79) 28% (22/79) Usual medical treatment 53% (87/163 )

17 Surgical intervention by 2 years Endometrial Ablation Hysterectomy LNG-IUS 4% (12/300) 6% (16/267) Usual medical treatment 6% (16/267 ) 6% (16/267)

18 Conclusions Both LNG-IUS and usual medical treatments reduce the adverse impact of HMB on women s lives over two years But LNG-IUS is the more effective Largest randomised trial Recruited the target sample Ethnically representative of the UK population over 60 centres used increasing generalisability Low loss to follow-up Outcomes over two years but 5 and 10 year follow up is intended

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21 Acknowledgements

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