Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets

• Registration Number: NCT00395993
• Lead Sponsor: American Regent, Inc.

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-04
• Study Completion: 2006-06
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Results First Submitted: 2013-09-16
• Results First Submitted QC: 2013-09-16
• Results First Posted: 2013-11-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 456

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM)	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 tablets	Ferrous Sulfate tablets	325 mg tablets TID on Days 0 through Day 42

Primary Outcome Measures

Name	Time	Method
Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL	Any time between baseline and the end of study or time to intervention

Trial Locations

Locations (1)

Luitpold Pharmaceuticals, Inc.; 🇺🇸 Norristown, Pennsylvania, United States