Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial

American Journal of Obstetrics and Gynecology
Tessa MaddenJeffrey F Peipert


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. 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. 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). The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.

Associated Clinical Trials

Nov 18, 2013·Jeffrey Peipert


Apr 1, 1993·Annals of Medicine·A FaúndesJ Díaz
Oct 1, 1996·Human Reproduction·J WitjaksonoP A Rogers
Sep 29, 2004·Contraception·Pisit Tantiwattanakul, Surasak Taneepanichskul
May 29, 2007·Contraception·Anja Guttinger, Hilary O D Critchley
Jun 15, 2010·American Journal of Obstetrics and Gynecology·Gina M SecuraJeffrey F Peipert

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