Comparing IV iron and oral iron for treating anemia in women with heavy menstrual bleeding
IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding
PHASE4 · Thomas Jefferson University · NCT04205266
This study is testing whether IV iron or oral iron pills work better to treat anemia in women who have heavy menstrual bleeding.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04205266 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of intravenous (IV) iron versus oral iron pills in treating anemia in women experiencing heavy menstrual bleeding. Participants will be randomly assigned to receive either IV iron (ferumoxytol) or oral iron (ferrous sulfate) and their blood counts will be monitored to assess improvement in anemia. Additionally, the study will evaluate the speed of response to treatment and gather participant feedback on their satisfaction with the treatment received. The goal is to determine which method is more effective and preferred by patients.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-50 who experience heavy menstrual bleeding and have anemia with hemoglobin levels below 11.5 g/dL.
Not a fit: Patients with suspected or confirmed malignancy, severe anemia requiring immediate intervention, or known iron overload will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from anemia due to heavy menstrual bleeding.
How similar studies have performed: Other studies have shown promising results in treating anemia with IV iron, suggesting that this approach may be effective, though this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anemia, Iron Deficiency, Heavy Menstrual Bleeding