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Iron Supplement

IV vs Oral Iron for Anemia Due to Heavy Menstrual Bleeding

Q: To what extent have other research initiatives explored the effects of intravenous iron?

Presently, there are 35 trials being conducted to investigate Intravenous Iron therapy. Of those active investigations, 7 have reached Phase 3 status. The majority of these clinical studies are taking place in Kano and Lagos, although a total of 154 sites across the globe hold research for this treatment option.

Q: What indications typically call for intravenous iron infusion?

Intravenous Iron is typically administered to lactating mothers. It can also be used in cases of folic acid deficiency, iron insufficiency, and nutritional supplementing needs.

Q: To what type of patient is enrollment in this trial appropriate?

Qualifying conditions for enrollment in this trial are menorrhagia and a patient age between 18-55. A total of 76 participants need to be recruited.

Q: Is the enrollment cutoff age for this clinical trial greater than 35 years old?

As specified in the inclusion criteria, only those aged between 18 and 55 may apply to this medical trial. There are 171 studies geared towards patients younger than 18 years old, while 488 investigate treatments for people above 65.

Q: What potential risks accompany intravenous iron infusions?

IV Iron has been approved and is thus rated at a 3 on our scale. This indicates that multiple rounds of data have validated its safety level.

Q: Are there currently spaces available for participation in this clinical research?

Affirmative. The information accessible on clinicaltrials.gov unveils that this medical research is actively seeking out eligible participants, with an initial posting date of February 14th 2020 and a recent update on October 18th 2022. 76 patients are needed for the experiment at one particular site.

Q: What is the total sample size of this experiment?

Affirmative. Evidence on clinicaltrials.gov shows that this research project, which was published in February 2020, is actively seeking participants. Specifically, the team needs 76 individuals to register from one single medical location.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days after initiation of treatment

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

Hypotension

Psychiatric disorders

Vomiting

Muscle spasms

Pyrexia

Arteriovenous fistula site complication

Blood and lymphatic system disorders

Upper respiratory tract infection

Fluid overload

Pain in extremity

Hypertension

Urinary tract infection

Hyperkalaemia

Investigations

Pruritus

Abdominal pain

Cough

Dyspnoea

Pneumonia

Sepsis

Non-cardiac chest pain

Dizziness

Arteriovenous fistula thrombosis

Fall

Acute respiratory failure

Arthralgia

Headache

Anaemia

Mental status changes

Pulmonary oedema

Cardiac failure congestive

Cellulitis

Angina pectoris

Gastrointestinal haemorrhage

Hip fracture

Cardiac arrest

Acute myocardial infarction

Pleural effusion

Cardio-respiratory arrest

Hypoglycaemia

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Immune system disorders

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Industry Sponsor

43 Previous Clinical Trials

11,290 Total Patients Enrolled

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,638 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent have other research initiatives explored the effects of intravenous iron?

"Presently, there are 35 trials being conducted to investigate Intravenous Iron therapy. Of those active investigations, 7 have reached Phase 3 status. The majority of these clinical studies are taking place in Kano and Lagos, although a total of 154 sites across the globe hold research for this treatment option."

Answered by AI

What indications typically call for intravenous iron infusion?

"Intravenous Iron is typically administered to lactating mothers. It can also be used in cases of folic acid deficiency, iron insufficiency, and nutritional supplementing needs."

Answered by AI

To what type of patient is enrollment in this trial appropriate?

"Qualifying conditions for enrollment in this trial are menorrhagia and a patient age between 18-55. A total of 76 participants need to be recruited."

Answered by AI

Is the enrollment cutoff age for this clinical trial greater than 35 years old?

"As specified in the inclusion criteria, only those aged between 18 and 55 may apply to this medical trial. There are 171 studies geared towards patients younger than 18 years old, while 488 investigate treatments for people above 65."

Answered by AI

What potential risks accompany intravenous iron infusions?

"IV Iron has been approved and is thus rated at a 3 on our scale. This indicates that multiple rounds of data have validated its safety level."

Answered by AI

Are there currently spaces available for participation in this clinical research?

"Affirmative. The information accessible on clinicaltrials.gov unveils that this medical research is actively seeking out eligible participants, with an initial posting date of February 14th 2020 and a recent update on October 18th 2022. 76 patients are needed for the experiment at one particular site."

Answered by AI

What is the total sample size of this experiment?

"Affirmative. Evidence on clinicaltrials.gov shows that this research project, which was published in February 2020, is actively seeking participants. Specifically, the team needs 76 individuals to register from one single medical location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Rebecca Mercier 2020. "IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205266.

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