Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

Inclusion Criteria:

1. Menstruating females 10-19 years of age

2. Non-smoker

3. Physician and patient have agreed to initiate Lysteda

4. Diagnosis of HMB based on the medical judgment of the principal or site investigator

5. Subjects must report menstrual periods occurring within 21-60 days from the start ofone period to the start of the next menstrual period

6. Negative pregnancy test

7. Informed consent obtained and signed

8. Informed assent obtained and signed

9. Understanding of study procedures

10. Ability to comply with study procedures for the entire length of the study

11. Subjects should be either sexually inactive (abstinent) or agree to use a barriermethod with spermicide in the event of sexual activity throughout the study period

Exclusion Criteria:

1. Active thromboembolic disease, history of thromboembolic disease (including retinalvein or artery occlusion), known inherited thrombophilia, or family history ofthrombosis in a first degree relative

2. Subject has a severe medical or psychiatric illness that, in the opinion of theInvestigator, would affect subject safety or compliance

3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorderssuch as type 1 von Willebrand disease, mild platelet function defects such as plateletstorage pool or release defects, and patients with bleeding due to Ehlers Danlossyndrome WILL be eligible to participate in the study.

4. Pregnancy within the past 6 months and/or breast-feeding

5. Use of hormonal contraception (estrogen and progestin) within 3 months of study entry,or anticipated need to initiate estrogen-containing hormonal contraception during thestudy period

6. Use of systemic steroids within 1 month of study entry

7. History of subarachnoid hemorrhage

8. History of Hepatitis B, C, or HIV

9. Baseline creatinine >20% above the upper limit of normal for age

10. Severe anemia (hemoglobin <8 g/dL)

11. Systolic blood pressure <85 or diastolic blood pressure <55

12. Heart rate <50 at time of screening

13. Use of intranasal DDAVP during menses will be permitted, but only if the patient has ahistory of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment,so that change in menstrual blood loss due to addition of Lysteda can be assessed. Useof one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the studyperiod, as is use of DDAVP in the event of severe epistaxis, trauma, or surgicalprocedures during the study period.