At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 456 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 1,000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets for Anemia. Completed, enrolled 456 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
Primary CompletionApr 2006
Study CompletionJun 2006
First PostedNov 2006
TodayJul 2026
First PostedNov 6, 2006
Enrollment StartMay 1, 2005
Primary CompletionApr 1, 2006
Study CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.7 years ago
Interventions
Ferric Carboxymaltose (FCM)drug
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
Ferrous Sulfate tabletsdrug
325 mg tablets TID on Days 0 through Day 42