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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 has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00548860
First received: October 22, 2007
Last updated: June 5, 2009
Last verified: June 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: 30 days ]

Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  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

ClinicalTrials.gov Identifier: NCT00548860     History of Changes
Other Study ID Numbers: 1VIT07017
Study First Received: October 22, 2007
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hemorrhage
Uterine Hemorrhage
Anemia, Iron-Deficiency
Hematologic Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
 Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013