A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiency

INTERVENTION: Trade Name: Floradix mit Eisen Pharmaceutical Form: Oral solution CAS Number: 299‐29‐6 Other descriptive name: FERROUS GLUCONATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 7.03‐7.74 Trade Name: ferro sanol duodenal mite 50 mg Pharmaceutical Form: Capsule, hard CAS Number: 14729‐84‐1 Other descriptive name: FERROUS (II) GLYCINE SULFATE COMPLEX Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 283,83 ‐ CONDITION: Pregnant women with diagnosed iron deficiency ; MedDRA version: 12.1 Level: LLT Classification code 10022976 Term: Iron deficiency anemia secondary to inadequate dietary iron intake PRIMARY OUTCOME: Main Objective: To gather information on the efficacy and safety profile of a long‐term treatment with Floradix® mit Eisen and to compare descriptively against a treatment with ferro sanol® duodenal mite 50mg Primary end point(s): The primary efficacy endpoint is the haemoglobin baseline change. Secondary Objective: ‐ INCLUSION CRITERIA: 1. Females who are = 18 years old 2. Confirmed singleton pregnancy 3. Pregnancy at = 23rd and = 26th week 4. Iron deficiency diagnosed before screening 5. Haemoglobin = 9,5 g/dl and = 11,2 g/dl determined at screening 6. Ferritin < 20 µg/L determined at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range