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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Ferric Carboxymaltose (FCM)
* Drug: Ferrous Sulfate tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Carboxymaltose (FCM)<br>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)<br>* 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<br>|
| Active Comparator: Ferrous Sulfate tablets<br>325 mg tablets TID on Days 0 through Day 42 | Drug: Ferrous Sulfate tablets<br>* 325 mg tablets TID on Days 0 through Day 42<br>* Other names: Oral Iron Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL |  | Any time between baseline and the end of study or time to intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, heavy uterine bleeding, menorrhagia, Anemia secondary to heavy uterine bleeding