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

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 currently recruiting participants.
Verified by Luitpold Pharmaceuticals, June 2008

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

ChemIDplus related topics:

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

Contacts


Contact: Angelia Butcher	610 650-4200	abutcher@lpicrd.com

Contact: Marc Tokars	610 650-4200	mtokars@lpicrd.com

Locations


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

Sponsors and Collaborators

Luitpold Pharmaceuticals

More Information

Study ID Numbers:	1VIT07017
First Received:	October 22, 2007
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00548860
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female

Metabolic Diseases

Uterine Hemorrhage

Hematologic Diseases

Anemia

Uterine Diseases

Iron Metabolism Disorders

Metabolic disorder

Hemorrhage

Iron

Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Pathologic Processes

Anemia, Hypochromic

ClinicalTrials.gov processed this record on October 17, 2008