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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.
ClinicalTrials.gov Identifier:
First Posted: October 24, 2007
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
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 Drug: Standard Medical Care (SMC) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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. ]
    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)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548860

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

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548860     History of Changes
Other Study ID Numbers: 1VIT07017
First Submitted: October 22, 2007
First Posted: October 24, 2007
Results First Submitted: October 8, 2013
Results First Posted: May 29, 2015
Last Update Posted: July 30, 2015
Last Verified: July 2015

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