Objective: To compare the effect of Kabi 2161 (a prodrug of tranexamic acid) and placebo on the reduction of menstrual blood loss in women suffering from idiopathic menorrhagia and to evaluate tolerance and effectiveness in a two-dose regimen.
Design: A randomised, double blind parallel group study using double dummy technique.
Setting: The departments of gynaecology at three medical centres in Sweden.
Subjects: Ninety-one outpatients visiting the gynaecological clinics from March 1991 to May 1992 were randomised into the study; 68 women fulfilled the study.
Interventions: Two run-in cycles, followed by administrations of Kabi 2161 (600 mg) tablets (1 four times daily or 2 twice daily) or placebo for the first five days of three menstrual cycles.
Main Outcome Measures: Objective measurement of the change in menstrual blood loss during the treatment periods compared with menstrual blood loss during the run-in periods.
Results: A statistically significant reduction of menstrual blood loss was found for each treatment group, compared with the placebo group (P < 0.001). The mean reduction with 95% confidence interval (CI) was 33% (24-40) in the group treated with 1 four times daily and 41% (33-49) in the group treated 2 twice daily. The difference between the treated groups in reduction of menstrual blood loss is not significant. No significant differences were found in the frequencies of reported unwanted events during run-in and during treatment between the different treatment groups. There were also no significant differences between the treatment groups and the placebo group.
Conclusion: Kabi 2161 in a dosage of 2.4 g per day gave a statistically significant reduction in objectively measured menstrual blood loss in a two (41%) as well as in a four (33%) dosage regimen compared with placebo. Frequency of unwanted events did not differ from those during run-in or from those in the placebo group. The optimal daily dosage needs to be further evaluated in a dose titration study.
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