Efficacy and Safety of Oral Tranexamic Acid in Women with Heavy Menstrual Bleeding and Fibroids
Author(s) -
Scott Evan Eder,
Jeffrey Baker,
Janet Gersten,
R. Garn Mabey,
Tammie L Adomako
Publication year - 2013
Publication title -
women s health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.363
H-Index - 39
eISSN - 1745-5065
pISSN - 1745-5057
DOI - 10.2217/whe.13.28
Subject(s) - tranexamic acid , medicine , menstrual bleeding , obstetrics , uterine fibroids , hysteroscopy , gynecology , blood loss , surgery
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.
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