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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• Female with iron deficiency anemia

• Hg 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