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.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals Identifier:
First received: October 22, 2007
Last updated: July 8, 2015
Last verified: July 2015

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
Drug: Ferric Carboxymaltose
Drug: Standard Medical Care (SMC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. [ Time Frame: From Day 0 through 30 days after the last dose of study drug. ] [ Designated as safety issue: Yes ]
    Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).

Enrollment: 2018
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM)
Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)
Drug: Ferric Carboxymaltose
Active Comparator: Standard Medical Care (SMC)
Varied as determined by the Investigator
Drug: Standard Medical Care (SMC)


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female with iron deficiency anemia
  • Hg </= 11 g/dL

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 month prior
  • 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
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Please refer to this study by its identifier: NCT00548860

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Luitpold Pharmaceuticals Identifier: NCT00548860     History of Changes
Other Study ID Numbers: 1VIT07017
Study First Received: October 22, 2007
Results First Received: October 8, 2013
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Uterine Hemorrhage
Anemia, Hypochromic
Genital Diseases, Female
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Uterine Diseases
Ferric Compounds
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015