Anemia, Iron Deficiency study: Ferric Derisomaltose vs Ferrous Sulfate
Official title IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
ClinicalTrials.gov ID: NCT05304442
What this study is testing
What is Ferric Derisomaltose 1000 mg in 10 mL IV Solution [Monoferric]?
An investigational intravenous iron therapy being studied for treating severe iron deficiency anemia in women with uterine bleeding in the emergency department. It is designed to deliver iron directly into the bloodstream to replenish iron stores.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how well IV ferric derisomaltose works against oral iron to treat severe iron‑deficiency anemia caused by uterine bleeding.
- Who it's for
- Women who have severe anemia from heavy menstrual bleeding and are in the emergency department.
- What's involved
- Participants receive either an IV iron infusion or take oral iron tablets, and will have blood tests and follow‑up visits to monitor their condition.
- Time commitment
- The trial lasts a few weeks, with several clinic visits and blood tests to track progress.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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;
- Patient able to return for planned follow-up visits at 3 and 6 weeks;
You likely can't join if
- Patient requiring hospitalization for any reason;
- Pregnant or nursing;
- Incarcerated/Prisoner;
- Weight \< 50 kg;
- History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;
- History of any anaphylactic allergy;
See the full eligibility criteria
- 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;
- Patient able to return for planned follow-up visits at 3 and 6 weeks;
- Patient able to be reached by telephone;
- Willing and able to provide consent for participation.
- Patient requiring hospitalization for any reason;
- Pregnant or nursing;
- Incarcerated/Prisoner;
- Weight \< 50 kg;
- History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;
- History of any anaphylactic allergy;
- Recent receipt of IV iron, erythropoiesis-stimulating agents;
- Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit;
- Parenteral iron within 4 weeks prior to ED visit;
- Scheduled/planned use of parenteral iron or ESA during study period;
- Receipt of blood transfusion at index visit;
- Planned elective major surgery during study period;
- Other current or recent hematologic therapy, as specified;
- Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication);
- Known bleeding disorder platelets \< 100,000';
- Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease;
- Acute heart failure or NYHA II-IV chronic heart failure;
- Inflammatory bowel disease;
- Cirrhosis or Decompensated liver disease;
- Chronic kidney disease, stage III or greater (eGFR \< 60);
- Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). \ Cystitis or cervicitis is NOT an exclusion
- Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.