Objective: The purpose of this study is to evaluate the effects of tranexamic acid and placebo on controlling irregular uterine bleeding secondary to Norplant use.
Materials and methods: A prospective randomized, double-blind, placebo-controlled trial was conducted. Sixty-eight Norplant users who had irregular bleeding were randomly allocated into two groups. A total of 34 users received tranexamic acid 500 mg twice a day for 5 days; the placebo was given to the other 34 users in the same manner. The total number of days of bleeding and spotting and the percentage of women whose irregular uterine bleeding was stopped was analyzed at the end of weeks 1 and 4.
Results: In the follow-up period (4 weeks after the initial treatment), a bleeding-free interval of > 20 days was found in 58.8% of the subjects treated with tranexamic acid and in 76.5% treated with placebo (p = .12). The percentage of subjects whose irregular uterine bleeding stopped during week 1 after the initial treatment was significantly higher in the tranexamic acid group than those in the placebo group (64.7% vs. 35.3%, p = .015). The mean number of bleeding/spotting days was not significantly different between the groups (15.4 vs. 12.7 days, p = .182).
Conclusions: Tranexamic acid for 5 days appears to be an effective treatment for irregular uterine bleeding associated with Norplant use only while it is being used. However, treatment for 5 days does not seem to provide long-term benefit.