RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-14
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04205266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 18-50.
  2. * Heavy menstrual bleeding, defined as self-report of bothersome periods with subjectively heavy flow or frequency greater than 7 bleeding days per month.
  3. * Anemia with hgb \<11.5 g/dL
  1. * Suspected/confirmed malignancy
  2. * Severe anemia currently requiring transfusion or emergent operative intervention
  3. * Allergy or contraindication to either study drug
  4. * Known iron overload
  5. * Known sickle cell disease

Contacts and Locations

Study Locations (Sites)

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-14
Study Completion Date2025-01

Study Record Updates

Study Start Date2020-02-14
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Anemia, Iron Deficiency
  • Heavy Menstrual Bleeding