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.
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.
- 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 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 HIV
