Phase 3
N=477
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00395993 ↗Enrolled (actual)
477
Serious AEs
1.3%
Results posted
Nov 2013
Primary outcome: Primary: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL — 187; 139 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric Carboxymaltose (FCM) (Drug); Ferrous Sulfate tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- American Regent, Inc.
- Primary completion
- Apr 2006
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 | — |
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
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
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.