Clinical trial NCT00395993: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: anemia
heavy uterine bleeding
menorrhagia
Anemia secondary to heavy uterine bleeding
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 456
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 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

Primary outcomes:
measure: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
timeFrame: Any time between baseline and the end of study or time to intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.