Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial - 02/02/12
Résumé |
Objective |
The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system.
Study Design |
We conducted a randomized controlled trial of naproxen, estradiol, or placebo that was administered over the first 12 weeks of levonorgestrel-releasing intrauterine system use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis.
Results |
There were 129 women who were assigned randomly to naproxen (n = 42 women), estradiol (n = 44 women), or placebo (n = 43 women). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared with placebo (42.9% vs 16.3%; P = .03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (adjusted relative risk, 0.90; 95% confidence interval, 0.84–0.97) compared with placebo. More frequent bleeding and spotting was observed in the estradiol group (adjusted relative risk, 1.25; 95% confidence interval, 1.17–1.34).
Conclusion |
The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.
Le texte complet de cet article est disponible en PDF.Key words : contraception, irregular bleeding, levonorgestrel intrauterine system, progestin-only contraception
Plan
| Funded by an American College of Obstetricians and Gynecologists/Bayer Healthcare Pharmaceuticals Research Award in Contraception; award number K12HD001459 from the Eunice Kennedy Shriver National Institute of Child Health & Human Development (T.M.); award number 5T35HL007815-15 from the National Institutes of Health (NIH); a Midcareer Investigator Award in Women's Health Research (K24 HD01298); and award number KL2RR024994 from the National Center for Research Resources, which is a component of the NIH and NIH Roadmap for Medical Research. |
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| T.M. is a speaker for Bayer Healthcare Pharmaceuticals' Mirena Speakers Bureau. The other authors report no conflicts of interest. |
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| The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of the National Institute of Child Health & Human Development, the National Center for Research Resources, or the National Institutes of Health. Information on National Center for Research Resources is available at www.ncrr.nih.gov/. Information on Re-engineering the Clinical Research Enterprise can be obtained from overview-translational.asp. |
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| Reprints will not be available from the authors. |
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| Cite this article as: Madden T, Proehl S, Allsworth JE, et al. Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. Am J Obstet Gynecol 2012;206:129.e1-8. |
Vol 206 - N° 2
P. 129.e1-129.e8 - février 2012 Retour au numéro
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