Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Inclusion Criteria:

• Female with iron deficiency anemia
• Hg </= 11 g/dL

Exclusion Criteria:

• Previous participation in a FCM trial
• Known Hypersensitivity to FCM
• History of anemia other that anemia due to heavy uterine bleeding or the post partum state
• current history of GI bleeding
• Received IV Iron within the month prior
• Anticipated need for surgery
• Malignancy history
• AST or ALT greater than normal
• Received an investigational drug within 30 days of screening
• Pregnant or sexually active females who are not willing ot use an effective form of birth control