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

Completed · Phase 3

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00548860

Run by

American Regent, Inc.

People needed

2018

Starts

2007-10-01

Expected to finish

2009-07-01

Last updated by the study team

2018-02-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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