Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

PHASE4CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2012

Conditions
Iron Deficiency
Interventions
DRUG

Ferinject

Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.

OTHER

Saline

Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.

Trial Locations (1)

1090

Universitätsklinik für Frauenheilkunde, Vienna

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SGS S.A.

INDUSTRY

lead

Vifor Pharma

INDUSTRY

NCT01110356 - Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age | Biotech Hunter | Biotech Hunter