A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding.

Author(s): Freeman EW, Lukes A, Vandrie D, Mabey RG, Gersten J, Adomako TL

Affiliation(s): Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.

Publication date & source: 2011-10, Am J Obstet Gynecol., 205(4):319.e1-7. Epub 2011 May 14.

OBJECTIVE: We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding. STUDY DESIGN: This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of >/=80 mL/cycle were randomized to receive either 1.95 g/d or 3.9 g/d of tranexamic acid or placebo for up to 5 days of menstrual bleeding. Primary efficacy endpoints were mean MBL reduction from baseline, mean MBL reductions that were considered "meaningful" by subjects, and mean MBL reductions from baseline >50 mL/cycle. Adverse events (AEs) were also assessed. RESULTS: Only the 3.9 g/d group met all 3 primary efficacy endpoints. AEs did not significantly differ among the 3 groups. There were no serious study-related AEs. CONCLUSION: The 3.9-g/d dose met all 3 primary efficacy endpoints, whereas the 1.95 g/d dose met 2 primary efficacy endpoints. Both doses were well tolerated. Copyright (c) 2011 Mosby, Inc. All rights reserved.