Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 69

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Dextran Injection	Iron Dextran Injection	Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM)	15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0

Primary Outcome Measures