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

NCT04205266 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-11-21

No results posted yet for this study

Summary

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.

Conditions

  • Anemia, Iron Deficiency
  • Heavy Menstrual Bleeding

Interventions

DRUG

Ferumoxytol

IV iron infusion

DRUG

Ferrous Sulfate

oral iron therapy

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205266 on ClinicalTrials.gov