Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: tranexamic acid
Intervention description: Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Cyclic Heavy Menstrual Bleed; Menorraghia

Summary:

      This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic
      acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female
      subjects ages 12-16 years with heavy menstrual bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy non-smoking (for at least 3 months) adolescent females 12-16 years
             of age with a history of at least 1 year of cyclic heavy menstrual bleeding (HMB)

          -  Subjects must report regularly occurring menstrual periods ≤10 days in duration, with
             21-45 days from the start of one period to the start of the next menstrual period

          -  Diagnosis of HMB based on the medical judgment of the Principal Investigator and will
             include the following criteria:

               1. Laboratory (including a bleeding disorders work-up) and Physical Findings;

               2. Limitations in Activities of Daily Living (ADL);

               3. Soiling, Staining and Clotting;

               4. Sanitary product usage and extent of MBL using a patient reported pictorial blood
                  assessment chart (PBAC).

          -  Subjects should either be sexually inactive (abstinent) or be using one of the
             following acceptable birth control methods and agree to continue its use throughout
             the study:

               -  copper intrauterine device (IUD) in place for at least 3 months;

               -  barrier methods (condom, diaphragm) with spermicide for at least 1 month prior to
                  the first dose and throughout the study.

          -  Negative pregnancy test results

          -  Subject's legally authorized representative (e.g., parent, guardian) must voluntarily
             sign a parental permission/informed consent form (ICF), and the subject must sign an
             assent, before the conduct of any study procedure

        Exclusion Criteria:

          -  Breast-feeding, or a history of abortion in the last 6 months

          -  Known bleeding or coagulation disorders based on medical history and/or laboratory
             results

          -  Known systemic hematologic diseases (e.g., all types of sickle-cell disease,
             thalassemia of all types, multiple myeloma, hemolytic anemia)

          -  Clinical evidence of any significant chronic illness, including cardiovascular, renal,
             neurologic, hepatic, endocrine, gastric, central nervous system disease, any
             psychiatric illness which could affect the efficacy or safety of study medication

          -  Subjects treated with systemic steroids in the last 1 month or hormonal treatment in
             the last 3 months

          -  A history or presence of any drug abuse or alcohol abuse within the last 1 year

          -  History of subarachnoid hemorrhage.

          -  Active thromboembolic disease; history of thrombosis or thromboembolism, including
             retinal vein or artery occlusion; an intrinsic risk of thrombosis or thromboembolism

          -  Use of vaginal hormone products (rings, creams, and gels) within 4 weeks prior to
             screening. Use of oral estrogen-, progestin-, or selective estrogen receptor within 8
             weeks prior to screening. Use of Lupron (3-month depot injection), estrogen pellet, or
             long-acting progestin injectables within 6 months prior to screening

          -  Subjects whose sitting blood pressure is less than 90/60 mmHg at screening

          -  Subjects whose pulse is lower than 50 b.p.m. at screening

          -  Subjects whose PR interval is >200 msec at screening and prior to dosing

          -  Subjects whose QTc interval >450 msec

          -  Subjects with positive tests for hepatitis B, C, or human immunodeficiency virus (HIV)