Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Completed · Phase 3

Conditions studied: Anemia

In brief

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Key facts

Study ID

NCT00396292

Run by

American Regent, Inc.

People needed

361

Starts

2005-02-01

Expected to finish

2006-02-01

Last updated by the study team

2018-02-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female Subjects able to give consent
• Post partum patients
• Baseline Hbg< /= 10
• Agree to practice birth control
• Demonstrate willingness to comply with protocol restrictions

You may not qualify if…

• Known hypersensitivity reaction to oral or IV iron (VIT-45)
• Documented history of discontinuing oral iron
• Significant bleeding
• History of anemia other that iron deficiency anemia
• Severe Psychiatric disorders
• Active severe infection
• Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
• Known HIV antibody
• Received investigational product within 30 days
• Alcohol abuse
• Hemochromatosis or other iron storage disorder

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.