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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 belowSelect...
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:Select...
I need to be hospitalized for any reason.
Select...
I am scheduled for a major surgery during the study.
Select...
I received a blood transfusion during my initial visit.
Select...
I weigh less than 50 kg.
Select...
I have recently received IV iron or drugs to increase red blood cell production.
Select...
I have an active rheumatic disease like rheumatoid arthritis.
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My kidney function is reduced (eGFR < 60).
Select...
I am scheduled to receive iron injections or erythropoiesis-stimulating agents.
Select...
I have heart failure that is moderate to severe.
Select...
I have been diagnosed with inflammatory bowel disease.
Select...
I have severe liver disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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 moreAwards & 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
1,028 Previous Clinical Trials
6,030,122 Total Patients Enrolled
Pharmacosmos Therapeutics, Inc.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to be hospitalized for any reason.I am scheduled for a major surgery during the study.I am cleared to leave the emergency department after treatment.I received a blood transfusion during my initial visit.You have had a severe allergic reaction in the past.I am not currently on or recently had blood-related treatment.I weigh less than 50 kg.I am using or will use blood thinners during the study, but not including NSAIDs.Your blood test shows low levels of ferritin, a sign of iron deficiency.I can attend follow-up visits at 3 and 6 weeks.I have recently received IV iron or drugs to increase red blood cell production.I have an active rheumatic disease like rheumatoid arthritis.I do not have a serious infection like pneumonia.I have been experiencing ongoing or repeated uterine bleeding.My kidney function is reduced (eGFR < 60).I have used drugs to help produce red blood cells within the last 8 weeks.You have a known bleeding disorder, and your platelet count is less than 100,000.I have received iron injections within the last 4 weeks.I can be contacted by phone.I am scheduled to receive iron injections or erythropoiesis-stimulating agents.I have heart failure that is moderate to severe.I have been diagnosed with inflammatory bowel disease.I have severe liver disease.You have had a bad reaction to any kind of injected iron before.Your hemoglobin level is lower than 9.0 g/dl, which means you have moderate to severe anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Iron
- Group 2: Intravenous Ferric Derisomaltose
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Iron-Deficiency Anemia Patient Testimony for trial: Trial Name: NCT05304442 — Phase 3