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Iron Supplement

IV vs Oral Iron for Anemia Due to Heavy Menstrual Bleeding

Phase 4
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heavy menstrual bleeding, defined as self-report of bothersome periods with subjectively heavy flow or frequency greater than 7 bleeding days per month
Women aged 18-50
Must not have
Known sickle cell disease
Severe anemia currently requiring transfusion or emergent operative intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days after initiation of treatment
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is studying whether intravenous (IV) iron is better than oral iron pills for correcting anemia in women who have heavy menstrual bleeding and anemia.

Who is the study for?
This trial is for women aged 18-50 with anemia (hemoglobin <11.5 g/dL) and heavy menstrual bleeding, which they find bothersome or lasts more than 7 days per month. It's not suitable for those needing urgent treatment for severe anemia, with suspected cancer, allergies to the drugs being tested, iron overload conditions, or sickle cell disease.
What is being tested?
The study compares two treatments for anemia in women with heavy periods: IV iron infusions using Feraheme (ferumoxytol) versus oral iron pills (ferrous sulfate). Participants will be randomly assigned to one of these treatments to see which works better and faster and which one patients prefer.
What are the potential side effects?
Possible side effects from IV iron include allergic reactions, headache, dizziness, nausea; while oral iron may cause stomach upset, constipation or diarrhea. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience heavy menstrual bleeding that bothers me.
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I am a woman aged between 18 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have sickle cell disease.
Select...
I need a blood transfusion or urgent surgery for my severe anemia.
Select...
I am not allergic to the study drug.
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I have or might have cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days after initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days after initiation of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin
Secondary study objectives
Therapeutic procedure
Quality of Life Score

Side effects data

From 2017 Phase 4 trial • 296 Patients • NCT01227616
38%
Gastrointestinal disorders
33%
Infections and infestations
31%
Injury, poisoning and procedural complications
29%
General disorders and administration site conditions
21%
Respiratory, thoracic and mediastinal disorders
20%
Musculoskeletal and connective tissue disorders
19%
Vascular disorders
18%
Nervous system disorders
16%
Metabolism and nutrition disorders
15%
Cardiac disorders
11%
Nausea
11%
Diarrhoea
10%
Skin and subcutaneous tissue disorders
9%
Hypotension
9%
Psychiatric disorders
8%
Vomiting
8%
Muscle spasms
8%
Pyrexia
7%
Arteriovenous fistula site complication
7%
Upper respiratory tract infection
7%
Fluid overload
7%
Blood and lymphatic system disorders
7%
Pain in extremity
7%
Hypertension
6%
Abdominal pain
6%
Urinary tract infection
6%
Cough
6%
Hyperkalaemia
6%
Pruritus
6%
Investigations
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Acute respiratory failure
4%
Arteriovenous fistula thrombosis
4%
Arthralgia
4%
Fall
4%
Headache
4%
Anaemia
3%
Mental status changes
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Cellulitis
2%
Angina pectoris
2%
Hip fracture
2%
Gastrointestinal haemorrhage
2%
Cardiac arrest
2%
Acute myocardial infarction
2%
Pleural effusion
2%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%
Immune system disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferumoxytol
Iron Sucrose

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IV IronExperimental Treatment1 Intervention
Will receive 2 infusions of 510mg of ferumoxytol, administered over 15 minutes, 3-8 days apart
Group II: Oral IronActive Control1 Intervention
Will receive 325mg ferrous sulfate tablets daily for 60 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iron
FDA approved

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Industry Sponsor
43 Previous Clinical Trials
11,238 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
465 Previous Clinical Trials
176,777 Total Patients Enrolled

Media Library

Ferrous Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04205266 — Phase 4
Iron-Deficiency Anemia Research Study Groups: Oral Iron, IV Iron
Iron-Deficiency Anemia Clinical Trial 2023: Ferrous Sulfate Highlights & Side Effects. Trial Name: NCT04205266 — Phase 4
Ferrous Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205266 — Phase 4
~0 spots leftby Jan 2025
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