title: Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial.
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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.
authors: Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
authors: Tessa
authors: T
authors: Madden
authors: Sarah
authors: S
authors: Proehl
authors: Jenifer E
authors: JE
authors: Allsworth
authors: Gina M
authors: GM
authors: Secura
authors: Jeffrey F
authors: JF
authors: Peipert
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004958:Estradiol / Q000627:therapeutic use*; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects*; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000627:therapeutic use; D008796:Metrorrhagia / Q000188:drug therapy* / Q000209:etiology; D009288:Naproxen / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004967:Estrogens; D004958:Estradiol; D009288:Naproxen; D016912:Levonorgestrel