IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorBaylor College of Medicine
About this trial
The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.
Eligibility criteria
Qualifiers
Sub-acute or chronic uterine blood loss;
Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;
Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;
Eligible for discharge from the ED following treatment;
Disqualifiers
Patient requiring hospitalization for any reason;
Pregnant or nursing;
Incarcerated/Prisoner;
Weight < 50 kg;
Trial design
Treatments tested in this trial
- Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
- Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Baylor College of Medicine
Lead sponsor
Pharmacosmos Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov