Clinical trial: Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding (NCT01307007)

Eligibility criteria:
Inclusion Criteria:

          -  Female subjects > or = to 18 years of age

          -  History of Heavy Uterine Bleeding within the past 6 months

          -  Screening visit central laboratory Hgb < 12 g/dL

          -  Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when transferrin
             saturation (TSAT) is < or = to 30%

          -  Demonstrate the ability to understand the requirements of the study, willingness to
             abide by study restrictions and to return for the required assessments

        Exclusion Criteria:

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose or iron
             dextran

          -  Previously randomized in a clinical study of ferric carboxymaltose

          -  Requires dialysis for treatment of chronic kidney disease

          -  Chronic kidney disease, marked by estimated glomerular filtration rate < 60
             ml/min/1.73m squared

          -  Previous kidney transplant

          -  History of primary hypophosphatemic disorder

          -  Hypophosphatemia < 2.6 mg/dl

          -  No evidence of iron deficiency

          -  During the 10 day period prior to screening has been treated with intravenous iron

          -  During the 30 day period prior to screening or during the study period has or will be
             treated with erythropoiesis stimulating agents (ESA) in a regimen that is off label

          -  During the 30 day period prior to screening or during the study period has or will be
             treated with a red blood cell transfusion, radiotherapy and/or chemotherapy

          -  During the 30 day period prior to screening or during the study period has or will
             require a surgical procedure that necessitates general anesthesia

          -  Any non-viral infection

          -  Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) at screening, as
             determined by central labs, greater than 1.5 times the upper limit of normal

          -  Known positive hepatitis with evidence of active disease

          -  Received an investigational drug within 30 days of screening

          -  Alcohol or drug abuse within the past 6 months

          -  Hemochromatosis or other iron storage disorders

          -  Malignancy history within the past 5 years other than basal or squamous cell skin
             cancer

          -  Any other laboratory abnormality, medical condition or psychiatric disorders which in
             the opinion of the investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements

          -  Pregnant or sexually-active female subjects who are of childbearing potential and who
             are not willing to use an acceptable form of contraception

          -  Untreated primary hyperparathyroidism

          -  Untreated gastrointestinal malabsorption (e.g., sprue)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? 1