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Hum. Reprod. Advance Access originally published online on February 16, 2006
Human Reproduction 2006 21(6):1467-1472; doi:10.1093/humrep/del029
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© The Author 2006. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Preventing copper intrauterine device removals due to side effects among first-time users: randomized trial to study the effect of prophylactic ibuprofen

David Hubacher1,3, Veronica Reyes2, Sonia Lillo2, Bosny Pierre-Louis1, Ana Zepeda2, Pai-Lien Chen1 and Horacio Croxatto2

1 Family Health International, Research Triangle Park, NC, USA and 2 Instituto Chileno de Medicina Reproductiva (ICMER), Santiago, Chile

3 To whom correspondence should be addressed at: Family Health International, P.O. Box 13950, Research Triangle Park, NC 27709, USA. E-mail: dhubacher{at}fhi.org

BACKGROUND: Increased menstrual bleeding and pain are the primary side effects that lead to early removal of the copper intrauterine device (IUD). Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) are proven treatments for such IUD-induced problems, but their effect on early IUD removal is unknown. METHODS: A total of 2019 first-time IUD users were recruited in Chile for this double-blind, randomized, placebo-controlled trial. Half of the participants were given ibuprofen and instructions to take 1200 mg daily during menses (for up to 5 days each cycle) for the first 6 months of IUD use. The other half were asked to take an identical appearing placebo in the same manner. The primary outcome was IUD removal within 12 months of insertion. RESULTS: A total of 1011 and 1008 women were randomly assigned to ibuprofen and placebo, respectively. During 12 months of observation, 190 had the device removed because of dysmenorrhoea and/or increased menstrual bleeding: 85 in the placebo group and 105 in the ibuprofen group. For ibuprofen users, the hazard ratio for removal for these IUD-induced side effects was 1.0 and 1.2 at 6 and 12 months, respectively (both not significant). CONCLUSION: Although increased menstrual bleeding and pain are common reasons for early IUD removal, prophylactic use of ibuprofen, at the dosage used here, does not reduce removal rates.

Key words: ibuprofen/IUD/prevention/removal/side effects


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