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Am J Obstet Gynecol. 2012 Feb;206(2):129.e1-8. doi: 10.1016/j.ajog.2011.09.021. Epub 2011 Sep 24.

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

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1
Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.

Abstract

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.

PMID:
22055339
PMCID:
PMC3268863
DOI:
10.1016/j.ajog.2011.09.021
[Indexed for MEDLINE]
Free PMC Article
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