Eder Scott, Baker Jeffrey, Gersten Janet, Mabey R Garn, Adomako Tammie L
Women's Health Research Center, Plainsboro, NJ, USA.
Womens Health (Lond). 2013 Jul;9(4):397-403. doi: 10.2217/whe.13.28. Epub 2013 May 9.
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.
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.
Tranexamic acid was well tolerated and reduced MBL in women with and without fibroids.
