Conditions: Anemia
Keywords: anemia heavy uterine bleeding menorrhagia Anemia secondary to heavy uterine bleeding
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 456
Healthy volunteers: no

Brief 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

Detailed description:
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.

Arms:
arm 1: 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 arm 2: 325 mg tablets TID on Days 0 through Day 42

Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: 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 intervention 2: 325 mg tablets TID on Days 0 through Day 42

Protocol document: