NCT01307007

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

A Randomized, Controlled Study to Investigate the Safety and Explore the Mechanism of Hypophosphatemia With Intravenous Ferric Carboxymaltose (FCM) Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Detailed description

To assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-05-01
• Completion: 2013-08-01
• First posted: 2011-03-02
• Last updated: 2018-02-19
• Results posted: 2017-06-27