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

Completed · Phase 3

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00395993

Run by

American Regent, Inc.

People needed

456

Starts

2005-05-01

Expected to finish

2006-06-01

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceuticals, Inc. — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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