At a glance
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Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
In Brief
A Phase 4 clinical trial evaluating Tranexamic Acid for Heavy Menstrual Bleeding. Completed, enrolled 32 participants across 5 sites.
Detailed Summary
This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life. Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents. Tranexamic acid is taken orally during the first 5 days of menstrual bleeding. The purposes of this study include: To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life. Lysteda has been approved by the Food and Drug Administration for use in patients \> than 18 years of age but not for younger patients.
Study Details
Timeline
Interventions
Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.