Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

August 31, 2013

Conditions
Iron Deficiency Anemia
Interventions
DRUG

Ferric Carboxymaltose (FCM)

15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0

DRUG

Iron Dextran Injection

Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY

NCT01307007 - Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding | Biotech Hunter | Biotech Hunter