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Levonorgestrel intrauterine system versus medical therapy for menorrhagia.

Author(s): Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J; ECLIPSE Trial Collaborative Group.

Collaborators: Kai J, Gupta J, Daniels J, Middleton L, Gray R, Pattison H, Gupta J, Kai J, Daniels J, Middleton L, Gray R, Pattison H, Gennard L, Leighton L, Darby E, Gross L, Hills R, Soneja H, Madari S, Snoxall S, Ingram L, Ingram J, Whatmough P, Prileszky G, Warlow C, Pickering O, Sargent S, Bryan S, Roberts T, Sanghera S, Takwoingi Y, Hilken N, Thornton J, Nazareth I, McPherson K, Nicholls E, Mackenzie B, Prentice A, Fountain J, Lumsden MA, Farrin A, Freemantle N, Kulshrestha RP, Kulshrestha S, O'Brien K, Coulson W, Craig J, Descals L, Kownacki A, Montague E, McKenzie B, Spooner CA, Sanganee N, Collier IP, Cope SJ, Goodwin A, Sheldrake LJ, Hanly C, Rajesh R, Hutchon S, Bingham T, Gupta JK, Ingram J, Ingram L, Soneja H, Madari S, Pettinger R, Sadler C, Brown M, Chaffey J, Cowan V, Brain L, Pabla HS, Godridge H, Horner ME, Horton PD, McGhee MF, McGrath M, Sumner KR, Ward-Campbell GJ, Williams S, Madhavan P, Brewin L, Glenchcliffe A, Young DJ, Heslington K, Hunt D, Saikia-Varman N, Jones M, Kavi L, Kidd L, Kai J, Zaman N, Piracha A, Ladha K, Morris M, O'Neill K, Patel JN, Waddell JE, Beighton PG, Cole FH, Edwards RM, Thompson A, Ayres J, Davies J, Poltock TL, Smith M, Talbot H, Cuthbert AJ, Horwell S, Jenkins C, Sinha G, Weaver K, Goodwin B, Patel RP, Debenham SE, Cartmill AD, Parker S, Pennington E, Pennington SJ, Young GB, Butler S, Hamilton PA, Warhad L, Elliott J, Lawrence E, North J, Elliott CI, Jerome S, Shipman PA, Bagchi R, Sheerin N, Blackwall C, Divers V, Siddall J, Parle HJ, Read S, Patodi SK, Amis S, Moloney S, Leung HH, Obi HU, Sidhu M, Ahmed N, Carter SR, Davies W, Harvey H, Khanna K, Rice PF, Shapiro L, Stone J, Parkin T, Craig JM, Moss PJ, Steele V, Cartwright JE, Edward MG, Harrison C, Francis R, Hassall P, Lloyd CE, Haynes J, Budh-Raja S, Budh-Raja VP, Patel SP, Redferne JH, Deb S, Lancaster A, Powell MC, Wragg J, O'Brien DC, Milner S, Taylor DW, Davies D, Tangri AK, Tangri C, Amer S, Prileszky G, Warlow C, Whatmough P, Duncan CH, Bower W, Irani S, Rajput S, Rajput VK, Young K, Cooper RE, Chin K, Scott D, Stacey J, Dadd C, Joshi KG, Sundar K, Broomhead CR, Clarke MP, Sangha E, Wood J, Fitzgerald-Jones B, Harley-Mason GR, Coward AD, Coward CM, Pash J, Little HM, Macdonald AG, Williams JP, Marshall J, McBride H, Watson KA, Clay SN, Walker SA, Billington J, Griffiths H, Mehta R, Emslie CJ, Bath SS, Chiam W, Gordon KR, Latthe M, Nandi DK, Lilford VA, Smith G, Godfrey E, Griffiths S, Porter C, Baird MS, Crombie C, O'Donnell D, Horton V, Kelsey RE, Fletcher JD, Hall F, Lenton C, Allen MP, Heanue J, McDonnell JH, Hancock J, Pattni BL, Banerjee ST, Pate S.

Affiliation(s): School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, United Kingdom.

Publication date & source: 2013, N Engl J Med. , 368(2):128-37

BACKGROUND: Menorrhagia is a common problem, yet evidence to inform decisions about therapy is limited. In a pragmatic, multicenter, randomized trial, we compared the levonorgestrel-releasing intrauterine system (levonorgestrel-IUS) with usual medical treatment in women with menorrhagia who presented to their primary care providers. METHODS: We randomly assigned 571 women with menorrhagia to treatment with levonorgestrel-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined estrogen-progestogen, or progesterone alone). The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) (ranging from 0 to 100, with lower scores indicating greater severity), assessed over a 2-year period. Secondary outcomes included general quality-of-life and sexual-activity scores and surgical intervention. RESULTS: MMAS scores improved from baseline to 6 months in both the levonorgestrel-IUS group and the usual-treatment group (mean increase, 32.7 and 21.4 points, respectively; P<0.001 for both comparisons). The improvements were maintained over a 2-year period but were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group (mean between-group difference, 13.4 points; 95% confidence interval, 9.9 to 16.9; P<0.001). Improvements in all MMAS domains (practical difficulties, social life, family life, work and daily routine, psychological well-being, and physical health) were significantly greater in the levonorgestrel-IUS group than in the usual-treatment group, and this was also true for seven of the eight quality-of-life domains. At 2 years, more of the women were still using the levonorgestrel-IUS than were undergoing the usual medical treatment (64% vs. 38%, P<0.001). There were no significant between-group differences in the rates of surgical intervention or sexual-activity scores. There were no significant differences in serious adverse events between groups. CONCLUSIONS: In women with menorrhagia who presented to primary care providers, the levonorgestrel-IUS was more effective than usual medical treatment in reducing the effect of heavy menstrual bleeding on quality of life. (Funded by the National Institute of Health Research Health Technology Assessment Programme; ECLIPSE Controlled-Trials.com number, ISRCTN86566246.).

Page last updated: 2013-02-10

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