Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding
Condition: Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Intervention: Tranexamic Acid
Intervention description: Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Heavy Menstrual Bleeding; HMB; Lysteda

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.
    

Eligibility criteria:

        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 of
             one 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 barrier
             method with spermicide in the event of sexual activity throughout the study period

        Exclusion Criteria:

          1. Active thromboembolic disease, history of thromboembolic disease (including retinal
             vein or artery occlusion), known inherited thrombophilia, or family history of
             thrombosis in a first degree relative

          2. Subject has a severe medical or psychiatric illness that, in the opinion of the
             Investigator, would affect subject safety or compliance

          3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders
             such as type 1 von Willebrand disease, mild platelet function defects such as platelet
             storage pool or release defects, and patients with bleeding due to Ehlers Danlos
             syndrome 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 the
             study 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 a
             history 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. Use
             of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study
             period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical
             procedures during the study period.