Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Anemia, Anemia |
| Therapuetic Areas: | Hematology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/22/2018 |
| Start Date: | October 2007 |
| End Date: | July 2009 |
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.
Heavy Uterine Bleeding and the Post Partum state.
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
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