title: A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-5509, USA. freemane@mail.med.upenn.edu
authors.forename: Ellen W
authors.initials: EW
authors.lastname: Freeman
authors.forename: Andrea
authors.initials: A
authors.lastname: Lukes
authors.forename: Douglas
authors.initials: D
authors.lastname: VanDrie
authors.forename: R Garn
authors.initials: RG
authors.lastname: Mabey
authors.forename: Janet
authors.initials: J
authors.lastname: Gersten
authors.forename: Tammie L
authors.initials: TL
authors.lastname: Adomako
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000933:Antifibrinolytic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D014148:Tranexamic Acid / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid