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Iron Supplement

IV Iron Therapy for Uterine Bleeding

Phase 3
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sub-acute or chronic uterine blood loss
Be older than 18 years old
Must not have
Patient requiring hospitalization for any reason
Planned elective major surgery during study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trialmeasures how well different treatments work to treat anemia caused by heavy bleeding in women.

Who is the study for?
This trial is for women with severe iron deficiency anemia due to uterine bleeding who can consent, are dischargeable from the emergency department, and can attend follow-ups. They must have a hemoglobin level of 9.0 g/dl or less and serum ferritin of 30 ng/mL or less. Exclusions include pregnancy, recent blood transfusions, major upcoming surgery, certain chronic diseases like heart failure or kidney disease, known allergies to iron treatments, and current infections.
What is being tested?
The study compares the effectiveness of IV Ferric Derisomaltose against oral Ferrous Sulfate in treating severe iron deficiency anemia caused by uterine bleeding in female patients at the emergency department. It's a randomized trial where participants will be assigned one of these two treatments.
What are the potential side effects?
Possible side effects may include allergic reactions such as itching or rash (more common with IV treatment), gastrointestinal issues like constipation or stomach pain (often associated with oral iron), headaches, dizziness, joint pains and muscle cramps.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing ongoing or repeated uterine bleeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need to be hospitalized for any reason.
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I am scheduled for a major surgery during the study.
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I received a blood transfusion during my initial visit.
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I weigh less than 50 kg.
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I have recently received IV iron or drugs to increase red blood cell production.
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I have an active rheumatic disease like rheumatoid arthritis.
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My kidney function is reduced (eGFR < 60).
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I am scheduled to receive iron injections or erythropoiesis-stimulating agents.
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I have heart failure that is moderate to severe.
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I have been diagnosed with inflammatory bowel disease.
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I have severe liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
mean change in hemoglobin concentration
Other study objectives
adverse events
mean change in ferritin
median number of return Emergency Department visits
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous Ferric DerisomaltoseExperimental Treatment1 Intervention
One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.
Group II: Oral IronActive Control1 Intervention
ferrous sulfate 65 mg once daily for 42 days.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,470 Total Patients Enrolled
Pharmacosmos Therapeutics, Inc.UNKNOWN

Media Library

Ferric Derisomaltose (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05304442 — Phase 3
Iron-Deficiency Anemia Research Study Groups: Oral Iron, Intravenous Ferric Derisomaltose
Iron-Deficiency Anemia Clinical Trial 2023: Ferric Derisomaltose Highlights & Side Effects. Trial Name: NCT05304442 — Phase 3
Ferric Derisomaltose (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304442 — Phase 3
Iron-Deficiency Anemia Patient Testimony for trial: Trial Name: NCT05304442 — Phase 3
~13 spots leftby Nov 2025
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