title: Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids.
  
  
  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.
  
  
  CONCLUSIONS
  Tranexamic acid was well tolerated and reduced MBL in women with and without fibroids.
authors: Women's Health Research Center, Plainsboro, NJ, USA. seeder@comcast.net. seeder@comcast.net
authors: Scott
authors: S
authors: Eder
authors: Jeffrey
authors: J
authors: Baker
authors: Janet
authors: J
authors: Gersten
authors: R Garn
authors: RG
authors: Mabey
authors: Tammie L
authors: TL
authors: Adomako
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000933:Antifibrinolytic Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D014148:Tranexamic Acid / Q000008:administration & dosage*; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid