Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

PHASE3CompletedINTERVENTIONAL
Enrollment

361

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

November 30, 2005

Study Completion Date

February 28, 2006

Conditions
Anemia
Interventions
DRUG

Oral iron tablets

325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

DRUG

VIT-45

A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY