drugset / Trial / NCT01307007

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

NCT01307007

Phase 2 Completed 69 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Timeline

Start
2010-09
Primary completion
2011-05
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Comparator Iron dextran Unknown 15 mg/kg Intravenous