Status:
COMPLETED
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00395993
Start Date
May 1 2005
End Date
June 1 2006
Last Update
February 20 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States, 19403