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

19C.864

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.

2020-02-14

2025-01-01

2025-01-01

Recruiting

Early phase I

76

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}

2023-11-21