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Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial
Andrea S Lukes1, Keith A Moore, Ken N Muse
1From 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.
Oral tranexamic acid effectively reduces heavy menstrual bleeding and improves quality of life for women. This treatment was well-tolerated, showing significant benefits in a placebo-controlled trial.
Area of Science:
- Gynecology
- Pharmacology
- Clinical Trials
Background:
- Heavy menstrual bleeding (HMB) significantly impacts women's quality of life.
- Oral tranexamic acid is being investigated as a treatment for HMB.
Purpose of the Study:
- To evaluate the efficacy and safety of an oral tranexamic acid formulation for treating heavy menstrual bleeding.
Main Methods:
- A double-blind, placebo-controlled study enrolled adult women with HMB (≥80 mL/cycle).
- Participants received oral tranexamic acid (3.9 g/d) or placebo for up to 5 days/cycle over six cycles.
- Primary endpoints included significant reduction in menstrual blood loss (MBL) compared to placebo, exceeding 50 mL, and a meaningful threshold (≥36 mL).
Main Results:
- Tranexamic acid significantly reduced MBL by -69.6 mL (40.4%) versus -12.6 mL (8.2%) in the placebo group (P<.001).
- The treatment met all primary efficacy endpoints, demonstrating a clinically meaningful reduction in MBL.
- Significant improvements were observed in quality of life, including social, physical, and work-related activities, with comparable safety to placebo.
Conclusions:
- Oral tranexamic acid is a well-tolerated and effective treatment for women experiencing heavy menstrual bleeding.
- The treatment significantly improves both menstrual blood loss and health-related quality of life.
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