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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Female subjects >/= 18 years of age

• History of Heavy uterine bleeding

• Hgb
• 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