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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Luitpold Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

Arm Description

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

325 mg tablets TID on Days 0 through Day 42

Outcomes

Primary Outcome Measures

Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL

Secondary Outcome Measures

Full Information

First Posted
November 2, 2006
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00395993
Brief Title
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Official Title
Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
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
Arm Title
Ferrous Sulfate tablets
Arm Type
Active Comparator
Arm Description
325 mg tablets TID on Days 0 through Day 42
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate tablets
Other Intervention Name(s)
Oral Iron Tablets
Intervention Description
325 mg tablets TID on Days 0 through Day 42
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Luitpold Pharmaceuticals, Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
18567277
Citation
Morrison J, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reprod Med. 2008 May;53(5):323-30.
Results Reference
result
PubMed Identifier
18752459
Citation
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. J Womens Health (Larchmt). 2008 Oct;17(8):1279-84. doi: 10.1089/jwh.2007.0605.
Results Reference
result
PubMed Identifier
19682342
Citation
Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22.
Results Reference
derived

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

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