Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Inclusion Criteria:

• Female subjects >/= 18 years of age
• History of Heavy uterine bleeding
• Hgb </= 11
• Practicing acceptable birth control
• Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

• Known Hypersensitivity to oral or IV iron
• Anemia other than iron deficiency anemia
• Iron storage disorders
• Initiation of treatment that may effect degree of heavy uterine bleeding
• Anticipated need for surgery
• Severe psychiatric disorder
• Active infection
• Positive Pregnancy test
• Known Hep B or C or Active Hepatitis
• Received investigational Drug within 30 days
• Alcohol or drug abuse