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 study investigates whether intravenous (IV) iron \[Feraheme (ferumoxytol) injection)\] is a better treatment than oral iron pills (ferrous sulfate) for correcting anemia in women who have heavy menstrual bleeding and anemia. Investigators will study whether women's blood counts respond better, respond more quickly, and if women prefer the IV treatment or the oral treatment. Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions. Investigators will then check whether and how quickly the anemia improves, and survey participants on how satisfied they were with the treatment.

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+