NCT00395993View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

April 30, 2006

Study Completion Date

June 30, 2006

Conditions
Anemia
Interventions
DRUG

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

DRUG

Ferrous Sulfate tablets

325 mg tablets TID on Days 0 through Day 42

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Inc., Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY

NCT00395993 - Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding | Biotech Hunter | Biotech Hunter