drugset / Trial / NCT00395993

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

NCT00395993 ↗

Phase 3 Completed 456 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2005-05
Primary completion
2006-04
Completion
2006-06

Outcome

Met primary endpoint

paper more patients assigned to ferric carboxymaltose responded with a hemoglobin (Hb) increase of 2.0 g/dL or more (82% vs. 62% PMID 19682342 ↗

paper p < 0.001 PMID 19682342 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral

Indications