Phase 3 Completed N=477 Randomized Treatment

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

Anemia

Source: ClinicalTrials.gov NCT00395993 ↗

Enrolled (actual)

477

Serious AEs

1.3%

Results posted

Nov 2013

Primary outcomePrimary: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL — 187; 139 participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL	187; 139	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00395993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.