NCT00395993

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
DRUG	Ferrous Sulfate tablets	325 mg tablets TID on Days 0 through Day 42

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-04-01
• Completion: 2006-06-01
• First posted: 2006-11-06
• Last updated: 2018-02-20
• Results posted: 2013-11-18

Locations

1 site across 1 country: United States