Phase 3
Completed N=2,018
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Source: ClinicalTrials.gov NCT00548860 ↗Enrolled (actual)
2,018
Serious AEs
1.4%
Results posted
May 2015
Primary outcomePrimary: Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. — 6; 22 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. |
6; 22 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00548860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.