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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Time Frame
Start Date: 2020-02-14
Estimated Completion Date: 2025-01
Participants
Target number of participants: 76
Treatments
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
Sponsors
Collaborators: AMAG Pharmaceuticals, Inc.
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov