A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial

Gupta JK, Daniels JP, Middleton LJ, Pattison HM, Prileszky G, Roberts TE, Sanghera S, Barton P, Gray R, Kai J
Record ID 32005000952
English
Authors' objectives: To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena®, Bayer) compared with usual medical treatment, with exploration of women's perspectives on treatment.
Authors' recommendations: The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause.
Details
Project Status: Completed
URL for project: http://www.nets.nihr.ac.uk/projects/hta/020602
Year Published: 2015
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta19880/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Cost-Benefit Analysis
  • Female
  • Intrauterine Devices, Medicated
  • Contraceptive Agents, Female
  • Endometriosis
  • Hormone Replacement Therapy
  • Leiomyoma
  • Levonorgestrel
  • Premenstrual Syndrome
  • Uterine Hemorrhage
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: <p>2009 Queen's Printer and Controller of HMSO</p>
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.