drugset / Trial / NCT01846507

Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

NCT01846507 ↗

Phase 4 Completed 32 enrolled Nationwide Children's Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-04
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1300 mg Oral

Indications

No indication recorded.