Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00395993
First received: November 2, 2006
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding


Condition Intervention Phase
Anemia
Drug: Ferric Carboxymaltose (FCM)
Drug: Ferrous Sulfate tablets
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: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL [ Time Frame: Any time between baseline and the end of study or time to intervention ] [ Designated as safety issue: No ]

Enrollment: 456
Study Start Date: May 2005
Study Completion Date: June 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM)
Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
Drug: Ferric Carboxymaltose (FCM)
Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
Active Comparator: Ferrous Sulfate tablets
325 mg tablets TID on Days 0 through Day 42
Drug: Ferrous Sulfate tablets
325 mg tablets TID on Days 0 through Day 42
Other Name: Oral Iron Tablets

Detailed Description:

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects >/= 18 years of age
  • History of Heavy uterine bleeding
  • Hgb </= 11
  • Practicing acceptable birth control
  • Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

  • Known Hypersensitivity to oral or IV iron
  • Anemia other than iron deficiency anemia
  • Iron storage disorders
  • Initiation of treatment that may effect degree of heavy uterine bleeding
  • Anticipated need for surgery
  • Severe psychiatric disorder
  • Active infection
  • Positive Pregnancy test
  • Known Hep B or C or Active Hepatitis
  • Received investigational Drug within 30 days
  • Alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395993

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

Publications:
Gordon S, Hadley PE, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
Gordon S, Hadley PE, Van Wyck DB, Mangione A. Iron Carboxymaltose, a New Intravenous Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. American College of Obstetricians & Gynecologists: 108S 2007.
Morrison J, Patel S, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the Prevalence and Impact of Anemia on Women Hospitalized for Gynecologic Conditions Asscoiated with Heavy Uterine Bleeding. The Journal of Reproductive Medicine: May;53(5):323-30 2008.
James AH, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. An Assessment of Medical Resource Utilization and Hospitalization Cost Associated with a Diagnosis of Anemia in Women with Obstetrical Bleeding in the United States. Journal of Women's Health 2008; Volume 17: 1279-1284.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00395993     History of Changes
Other Study ID Numbers: 1VIT04002/003
Study First Received: November 2, 2006
Results First Received: September 16, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
anemia
heavy uterine bleeding
menorrhagia
Anemia secondary to heavy uterine bleeding

Additional relevant MeSH terms:
Anemia
Hemorrhage
Uterine Hemorrhage
Hematologic Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014