Recruiting

IV Iron vs. Oral Iron

Sponsor:

Thomas Jefferson University

Code:

NCT04205266

Conditions

Anemia, Iron Deficiency

Heavy Menstrual Bleeding

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Ferumoxytol

Ferrous Sulfate

Study Details

Brief 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

Study ID

NCT04205266

Start date

Feb 14, 2020

Status verified date

Nov, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women aged 18-50.
  • Heavy menstrual bleeding, defined as self-report of bothersome periods with subjectively heavy flow or frequency greater than 7 bleeding days per month.
  • Anemia with hgb <11.5 g/dL

Exclusion Criteria:

  • Suspected/confirmed malignancy
  • Severe anemia currently requiring transfusion or emergent operative intervention
  • Allergy or contraindication to either study drug
  • Known iron overload
  • Known sickle cell disease

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV Iron

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

active comparator: Oral Iron

Will receive 325mg ferrous sulfate tablets daily for 60 days

Interventions

Ferumoxytol

IV iron infusion

Ferrous Sulfate

oral iron therapy

Primary outcome measure

  • Hemoglobin [ Time Frame: 60 days after initiation of treatment ]
  • Hemoglobin [ Time Frame: 30 days after initiation of treatment ]
  • Hemoglobin [ Time Frame: 14 days after initiation of treatment ]

Central Contacts and Locations

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Rebecca Mercier, MD MPH

215-955-5000rebecca.mercier@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Nov 21, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2023-11-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.