Study to Investigate the Safety of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

This study is ongoing, but not recruiting participants.

First Received: October 22, 2007 Last Updated: January 14, 2009 History of Changes

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00548860

Purpose

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Condition	Intervention	Phase
Anemia	Drug: Ferric Carboxymaltose	Phase III

MedlinePlus related topics: Anemia Postpartum Care Vaginal Bleeding

Drug Information available for: Ferric carboxymaltose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Multi-Center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

safety and tolerability [ Time Frame: 30 days ]

Study Start Date:

October 2007

Eligibility

Genders Eligible for Study:

Female

Criteria

Inclusion Criteria:

Female with iron deficiency anemia
Hg </= 11

Exclusion Criteria:

Previous participation in a FCM trial
Known Hypersensitivity to FCM
History of anemia other that anemia due to heavy uterine bleeding or the post partum state
current history of GI bleeding
Received IV Iron within the last 3 months
Anticipated need for surgery
Malignancy history
AST or ALT greater than normal
Received an investigational drug within 30 days of screening
Pregnant or sexually active females who are not willing ot use an effective form of birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548860

Locations

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

Luitpold Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	1VIT07017
Study First Received:	October 22, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00548860 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Uterine Hemorrhage
Ferric Compounds
Hematologic Diseases
Hematinics
Anemia
Uterine Diseases

Iron Metabolism Disorders
Hemorrhage
Anemia, Iron-Deficiency
Genital Diseases, Female
Metabolic Disorder
Iron

Additional relevant MeSH terms:

Metabolic Diseases
Uterine Hemorrhage
Ferric Compounds
Hematologic Diseases
Hematinics
Hematologic Agents
Anemia
Anemia, Hypochromic

Uterine Diseases
Iron Metabolism Disorders
Hemorrhage
Pharmacologic Actions
Anemia, Iron-Deficiency
Genital Diseases, Female
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on May 07, 2009