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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395993
• Other study ID #: 1VIT04002/003
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: January 22, 2018
• Start date: May 2005
• Est. completion date: June 2006

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: June 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Hemorrhage
• Uterine Hemorrhage

Intervention

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
• Ferrous Sulfate tablets
325 mg tablets TID on Days 0 through Day 42

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals, Inc.	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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.

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.

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). 2 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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