Efficacy and Safety of Oral Tranexamic Acid in Women with Heavy Menstrual Bleeding and Fibroids. (July 2013)

• Record Type: Journal Article
• Authors: Eder, Scott; Baker, Jeffrey; Gersten, Janet; Mabey, R Garn; Adomako, Tammie L
• Is Part Of: Women's health. Volume 9:Number 4(2013)
• Page Start: 397
• Page End: 403
• Publication Date: 2013-07
• Subjects: fibroid -- heavy menstrual bleeding -- menorrhagia -- tranexamic acid -- women's health; Gynecology -- Periodicals; Obstetrics -- Periodicals; Women -- Health and hygiene -- Periodicals; 618.05
• DOI: 10.2217/WHE.13.28
• Languages: English
• ISSNs: 1745-5057

Abstract

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.