drugset / Trial / NCT00395993
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2005-05
- Primary completion
- 2006-04
- Completion
- 2006-06
Publications
- Results Gordon S, Hadley PE, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
- Results Gordon S, Hadley PE, Van Wyck DB, Mangione A. Iron Carboxymaltose, a New Intravenous Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. American College of Obstetricians & Gynecologists: 108S 2007.
- Results Morrison J, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reprod Med. 2008 May;53(5):323-30.
- Results James AH, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. An assessment of medical resource utilization and hospitalization cost associated with a diagnosis of anemia in women with obstetrical bleeding in the United States. J Womens Health (Larchmt). 2008 Oct;17(8):1279-84. doi: 10.1089/jwh.2007.0605.
- Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 325 mg | Oral |