title: Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial.
abstract: OBJECTIVE
  To assess the efficacy of tranexamic acid or mefenamic acid in the management of the initial "nuisance" bleeding or spotting in the period immediately after placement of the levonorgestrel-releasing intrauterine system.
  
  
  METHODS
  Women were randomized after levonorgestrel-releasing intrauterine system placement to oral tranexamic acid (500 mg), mefenamic acid (500 mg), or placebo three times daily during bleeding or spotting episodes over a 90-day treatment period. Treatment was initiated from onset of a bleeding or spotting episode and continued until the first day after bleeding or spotting stopped and restarted with a new bleeding or spotting episode. The primary efficacy variable was reduction in the number of bleeding or spotting days. Tranexamic acid and mefenamic acid were compared with placebo using a one-sided Wilcoxon rank-sum test. Bonferroni-Holm adjustment was used to account for multiple testing.
  
  
  RESULTS
  A total of 204 women were screened; 187 were randomized to tranexamic acid (n=63), mefenamic acid (n=63), or placebo (n=61). The median number of bleeding or spotting days experienced during treatment was 25, 29, and 33 days in the three groups, respectively. The median number of bleeding or spotting days was reduced by 6 days (95% confidence interval [CI] -14.0 to 1.0, P=.049) with tranexamic acid and by 3 days (95% CI -11.0 to 5.0, P=.229) with mefenamic acid compared with placebo. The relative risk of bleeding or spotting compared with placebo with tranexamic acid and mefenamic acid was 0.82 (95% CI 0.65-1.03) and 0.89 (95% CI 0.71-1.11), respectively. Most women (85% or more) were satisfied with the levonorgestrel-releasing intrauterine system across the groups.
  
  
  CONCLUSIONS
  Tranexamic acid and mefenamic acid during the first 90 days after levonorgestrel-releasing intrauterine system placement do not alleviate "nuisance" bleeding or spotting.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT01295294.
  
  
  METHODS
  I.
authors: Medicus AS, Trondheim, Norway; Global Medical Affairs Women's HealthCare and Global Clinical Statistics, Bayer Healthcare, Berlin, Germany; Gynecology, Skt Anne Plads, Odense, Denmark; and Town Centre Medical Practice, Cork, Ireland.
authors: Terje
authors: T
authors: Sørdal
authors: Pirjo
authors: P
authors: Inki
authors: John
authors: J
authors: Draeby
authors: Mary
authors: M
authors: O'Flynn
authors: Thomas
authors: T
authors: Schmelter
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects*; D016912:Levonorgestrel / Q000009:adverse effects*; D008528:Mefenamic Acid / Q000627:therapeutic use*; D008796:Metrorrhagia / Q000139:chemically induced* / Q000188:drug therapy*; D011446:Prospective Studies; D014148:Tranexamic Acid / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000933:Antifibrinolytic Agents; D003271:Contraceptive Agents, Female; D008528:Mefenamic Acid; D016912:Levonorgestrel; D014148:Tranexamic Acid
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