Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2018 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ferric Carboxymaltose (FCM)

Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)

Group Type EXPERIMENTAL

Ferric Carboxymaltose

Intervention Type DRUG

Standard Medical Care (SMC)

Varied as determined by the Investigator

Group Type ACTIVE_COMPARATOR

Standard Medical Care (SMC)

Intervention Type DRUG

Interventions

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Ferric Carboxymaltose

Intervention Type DRUG

Standard Medical Care (SMC)

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No