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

• ClinicalTrials.gov Identifier: NCT00395993
• Recruitment Status: Completed
• First Posted: November 6, 2006
• Results First Posted: November 18, 2013
• Last Update Posted: February 20, 2018
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Anemia	Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 456 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2005
• Actual Primary Completion Date: April 2006
• Actual Study Completion Date: June 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM); Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered	Drug: Ferric Carboxymaltose (FCM); Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
Active Comparator: Ferrous Sulfate tablets; 325 mg tablets TID on Days 0 through Day 42	Drug: Ferrous Sulfate tablets; 325 mg tablets TID on Days 0 through Day 42; Other Name: Oral Iron Tablets

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL [ Time Frame: Any time between baseline and the end of study or time to intervention ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

American Regent, Inc.

More Information

Publications of 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.

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.

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.

James A, Patel S, Dinh Q. Impact of Anemia on Medical Resource Utilization and Hospitalization Cost in Women with Obstretrical Bleeding. The Journal of Reproductive Medicine 2008.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00395993
• Other Study ID Numbers: 1VIT04002/003
• First Posted: November 6, 2006
• Results First Posted: November 18, 2013
• Last Update Posted: February 20, 2018
• Last Verified: January 2018

Keywords provided by American Regent, Inc.:

anemia; heavy uterine bleeding; menorrhagia; Anemia secondary to heavy uterine bleeding

Additional relevant MeSH terms:

Uterine Hemorrhage; Anemia; Hemorrhage; Hematologic Diseases; Pathologic Processes; Uterine Diseases