Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial.
OBJECTIVE
To assess the efficacy and safety of an oral formulation of tranexamic acid for the treatment of heavy menstrual bleeding.


METHODS
Adult women with heavy menstrual bleeding (mean menstrual blood loss 80 mL or more per cycle) were enrolled in a double-blind, placebo-controlled study. After two pretreatment menstrual cycles, women were randomized to receive tranexamic acid 3.9 g/d or placebo for up to 5 days per menstrual cycle through six cycles. To meet the prespecified three-component primary efficacy end point, mean reduction in menstrual blood loss from baseline with tranexamic acid treatment needed to be 1) significantly greater than placebo, 2) greater than 50 mL, and 3) greater than a predetermined meaningful threshold (36 mL or higher). Health-related quality of life was measured using a validated patient-reported outcome instrument.


RESULTS
Women who received tranexamic acid (n=115) met all three primary efficacy end points: first, a significantly greater reduction in menstrual blood loss of -69.6 mL (40.4%) compared with -12.6 mL (8.2%) in the 72 women who received placebo (P<.001); reduction of menstrual blood loss exceeding a prespecified 50 mL; and last, reduction of menstrual blood loss considered meaningful to women. Compared with women receiving placebo, women treated with tranexamic acid experienced significant improvements in limitations in social or leisure and physical activities, work inside and outside the home, and self-perceived menstrual blood loss (P<.01). The majority of adverse events were mild to moderate in severity, and the incidence of gastrointestinal adverse events was comparable with placebo.


CONCLUSIONS
In this study, a new oral tranexamic acid treatment was well tolerated and significantly improved both menstrual blood loss and health-related quality of life in women with heavy menstrual bleeding.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386308.


METHODS
I.
Lukes
Andrea S
AS
From the Carolina Women's Research and Wellness Center, Durham, North Carolina; Xanodyne Pharmaceuticals, Inc., Newport, Kentucky; the Department of Obstetrics and Gynecology, University of Kentucky, Lexington, Kentucky; the New Age Medical Research Corporation, Miami, Florida; the Cleveland Clinic Fertility Center, Canfield, Ohio; the Department of Obstetrics and Gynecology, Danderyds Hospital, Stockholm, Sweden; the University of Alabama at Birmingham, Birmingham, Alabama; The Center for Women's Health & Wellness, LLC, Plainsboro, New Jersey; the University of Miami, Miami, Florida; the University of Washington, Seattle, Washington; and ARSTAT Analysis, Flemington, New Jersey.
Moore
Keith A
KA
Muse
Ken N
KN
Gersten
Janet K
JK
Hecht
Bryan R
BR
Edlund
Måns
M
Richter
Holly E
HE
Eder
Scott E
SE
Attia
George R
GR
Patrick
Donald L
DL
Rubin
Arkady
A
Shangold
Gary A
GA
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000933:Antifibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D009043:Motor Activity; D011788:Quality of Life; D014148:Tranexamic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid