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

This study has been completed.

First Received: November 2, 2006 Last Updated: October 14, 2008 History of Changes

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00395993

Purpose

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	Intervention	Phase
Anemia	Drug: Intravenous iron Drug: Oral iron	Phase III

MedlinePlus related topics: Anemia Vaginal Bleeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Number of subjects achieving clinical success

Secondary Outcome Measures:

Mean changes in Iron Indices
Quality of Life changes

Estimated Enrollment:	390
Study Start Date:	February 2005
Estimated Study Completion Date:	April 2006

Detailed Description:

This is an open-label, randomized, Phase III, active controlled, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395993

Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators

Study Director:

Antoinette Mangione, MD PharmD

Luitpold Pharmaceuticals

More Information

Publications:

Morrison J, Patel S, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the Prevalence and Impact of Anemia on Women Hospitalized for Gynecologic Conditions Asscoiated with Heavy Uterine Bleeding. The Journal of Reproductive Medicine: May;53(5):323-30 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. Journal of Women's Health 2008; Volume 17: 1279-1284.

Study ID Numbers:	1VIT04002/003
Study First Received:	November 2, 2006
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00395993 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:

anemia
heavy uterine bleeding
menorrhagia
Anemia secondary to heavy uterine bleeding

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Hemorrhage
Hematologic Diseases
Anemia
Neoplasm Metastasis
Uterine Diseases

Trace Elements
Micronutrients
Menorrhagia
Hemorrhage
Iron

Additional relevant MeSH terms:

Uterine Hemorrhage
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Anemia
Uterine Diseases
Trace Elements

Hemorrhage
Pharmacologic Actions
Genital Diseases, Female
Pathologic Processes
Micronutrients
Iron

ClinicalTrials.gov processed this record on May 07, 2009