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

NCT00395993 | Completed Phase 3 Results

• 1 other identifier: 1VIT04002/003
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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

Conditions

Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL

  Any time between baseline and the end of study or time to intervention

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

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)

Ferrous Sulfate tablets

ACTIVE COMPARATOR

325 mg tablets TID on Days 0 through Day 42

Drug: Ferrous Sulfate tablets

Interventions

Ferric Carboxymaltose (FCM) DRUG

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

Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets DRUG

325 mg tablets TID on Days 0 through Day 42

Also known as: Oral Iron Tablets

Ferrous Sulfate tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 18567277 RESULT

• 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.

  PMID: 18752459 RESULT

• 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.

  PMID: 19682342 DERIVED

MeSH Terms

Conditions

Anemia; Menorrhagia

Interventions

ferric carboxymaltose; Iron-Dextran Complex; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: May 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: June 1, 2006
• Last Updated: February 20, 2018
• Results First Posted: November 18, 2013

Record last verified: 2018-01

Locations

US (1)