IV vs Oral Iron for Anemia Due to Heavy Menstrual Bleeding

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Disqualifiers: Malignancy, Severe anemia, Iron overload, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 60 days

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether IV iron infusions or oral iron pills better treat anemia caused by heavy menstrual bleeding. Researchers aim to determine which method improves blood counts faster and which one participants prefer. Women with bothersome periods lasting more than seven days a month and low blood iron levels (anemia) may be suitable for this study. Participants will either take daily iron pills (Ferrous Sulfate) or receive two IV iron infusions (Ferumoxytol, also known as Feraheme) and share their experiences. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, seeking to understand how they benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that ferumoxytol, the IV iron treatment under study, is generally well-tolerated by people with iron deficiency anemia. It is effective for those who couldn't use or didn't benefit from oral iron. Serious side effects are rare, and most patients do not experience severe issues with ferumoxytol.

Ferrous sulfate, the oral iron pill being compared, is also widely used and well-understood. It has been available for a long time and is usually safe, though some people might experience stomach upset or constipation.

Both treatments have been used by many people before, and serious problems are uncommon. This study aims to determine if one treatment is better or faster at improving anemia in women with heavy menstrual bleeding. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for anemia due to heavy menstrual bleeding because they offer different approaches to iron supplementation. Unlike traditional oral iron supplements like ferrous sulfate, which can take weeks to improve symptoms, ferumoxytol is administered intravenously and may provide faster relief with just two infusions. This IV method allows for a higher dose of iron to be delivered directly into the bloodstream, potentially improving iron levels more quickly and efficiently. These unique features could lead to more rapid improvement in symptoms for those struggling with anemia from heavy menstrual bleeding.

What evidence suggests that this trial's treatments could be effective for anemia due to heavy menstrual bleeding?

Research has shown that ferumoxytol, an intravenous iron treatment, effectively treats iron-deficiency anemia, particularly when iron pills are ineffective or unsuitable. In this trial, some participants will receive ferumoxytol. Studies found that patients who received ferumoxytol had significantly improved iron levels, with many requiring no further treatments. For women with heavy periods and anemia, ferumoxytol significantly increased hemoglobin levels, the protein in red blood cells that carries oxygen. This makes ferumoxytol a strong choice for quickly improving anemia in these women. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I experience heavy menstrual bleeding that bothers me.

Your hemoglobin level is lower than 11.5 grams per deciliter.

I am a woman aged between 18 and 50.

Exclusion Criteria

I have sickle cell disease.

I need a blood transfusion or urgent surgery for my severe anemia.

I am not allergic to the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Enrollment and Randomization

Participants are enrolled and randomized to either oral iron or IV iron treatment groups

1 day

1 visit (in-person)

Treatment

Participants receive either oral iron tablets daily or two IV iron infusions 3-8 days apart

60 days

2 visits (in-person for IV group), self-administration for oral group

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction with treatment

60 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ferrous Sulfate
• Ferumoxytol

Trial Overview 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.

How Is the Trial Designed?

Group I: IV Iron Experimental Treatment 1 Intervention

Will receive 2 infusions of 510mg of ferumoxytol, administered over 15 minutes, 3-8 days apart

Group II: Oral Iron Active Control 1 Intervention

Will receive 325mg ferrous sulfate tablets daily for 60 days

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

AMAG Pharmaceuticals, Inc.

Industry Sponsor

Trials

44

Recruited

11,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4223995/

Efficacy and safety of IV ferumoxytol for adults with iron ... Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04205266

IV Iron vs Oral Iron for Treatment of Anemia in Women With ... Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4225478/

A Phase III, randomized, open-label trial of ferumoxytol ... Ferumoxytol-treated patients showed a statistically significant (P = 0.0048) greater increase in TSAT from Baseline to Week 5 (14.5%) compared with the increase ...

4. ashpublications.org ashpublications.org/blood/article/132/Supplement%201/4894/261981/The-Safety-and-Efficacy-of-Ferumoxytol-in-the

The Safety and Efficacy of Ferumoxytol in the Treatment of Iron ... Ferumoxytol Treatment Results in Robust Hemoglobin ... iron-deficiency anemia due to heavy menstrual bleeding: a single-center experience.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119654777

Safety and Efficacy Of Ferumoxytol For The Episodic ... Overall, 61% of FER treated patients never required a 2nd course of treatment. Statistically significant (p<0.0001) increases in mean TSAT from TP Baseline to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11869313/

Iron deficiency anemia in patients with heavy menstrual ... Patients with IDA and HMB experienced substantial delays from symptom onset to subsequent IVI treatment, demonstrating a gap in management.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04205266

IV Iron vs Oral Iron for Treatment of Anemia in Women With ... Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions.