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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days after initiation of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I experience heavy menstrual bleeding that bothers me.
Select...
I am a woman aged between 18 and 50.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin
Secondary outcome measures
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%
Blood and lymphatic system disorders
7%
Upper respiratory tract infection
7%
Arteriovenous fistula site complication
7%
Fluid overload
7%
Pain in extremity
7%
Hypertension
6%
Urinary tract infection
6%
Hyperkalaemia
6%
Investigations
6%
Pruritus
6%
Abdominal pain
6%
Cough
6%
Dyspnoea
6%
Pneumonia
5%
Non-cardiac chest pain
5%
Sepsis
5%
Dizziness
4%
Fall
4%
Arteriovenous fistula thrombosis
4%
Acute respiratory failure
4%
Arthralgia
4%
Headache
4%
Anaemia
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Mental status changes
3%
Cellulitis
2%
Gastrointestinal haemorrhage
2%
Angina pectoris
2%
Hip fracture
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

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
451 Previous Clinical Trials
148,602 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
~9 spots leftby Jan 2025
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