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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395993

1VIT04002/003

Details and patient eligibility

About

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

Full 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.

Enrollment: 456 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects >/= 18 years of age
• History of Heavy uterine bleeding
• Hgb </= 11
• Practicing acceptable birth control
• Demonstrate ability to understand and comply with protocol

Exclusion criteria

• Known Hypersensitivity to oral or IV iron
• Anemia other than iron deficiency anemia
• Iron storage disorders
• Initiation of treatment that may effect degree of heavy uterine bleeding
• Anticipated need for surgery
• Severe psychiatric disorder
• Active infection
• Positive Pregnancy test
• Known Hep B or C or Active Hepatitis
• Received investigational Drug within 30 days
• Alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

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

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

Active Comparator group

Description:

325 mg tablets TID on Days 0 through Day 42

Treatment:

Drug: Ferrous Sulfate tablets