Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids.

AIM

To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids.

MATERIALS & METHODS: This was a pooled analysis of two pivotal Phase III studies. Fibroids were evaluated by transvaginal ultrasonography. Menstrual blood loss (MBL) was measured via a validated alkaline hematin method.

RESULTS

In women with and without fibroids, mean MBL was reduced compared with placebo across all treatment cycles (p < 0.001). Within the tranexamic acid group, more statistically significant (p < 0.001) reductions in MBL compared with placebo occurred in women with fibroids than in those without fibroids. Adverse events were similar between treatment groups.

CONCLUSION

Tranexamic acid was well tolerated and reduced MBL in women with and without fibroids.