Clinical trial: Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding (NCT01190150)

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)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 16 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction