NCT04205266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

December 12, 2019

Last Update Submit

November 20, 2023

Conditions

Anemia, Iron DeficiencyHeavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin

    Blood draw to check complete blood count

    60 days after initiation of treatment

  • Hemoglobin

    Blood draw with check complete blood count

    30 days after initiation of treatment

  • Hemoglobin

    Blood draw with check complete blood count

    14 days after initiation of treatment

Secondary Outcomes (2)

  • Participant satisfaction with treatment

    60 days after initiation of treatment

  • Quality of Life Score

    60 days after initiation of treatment

Study Arms (2)

IV Iron

EXPERIMENTAL

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

Drug: Ferumoxytol

Oral Iron

ACTIVE COMPARATOR

Will receive 325mg ferrous sulfate tablets daily for 60 days

Drug: Ferrous Sulfate

Interventions

FerumoxytolDRUG

IV iron infusion

Also known as: Feraheme
IV Iron
Ferrous SulfateDRUG

oral iron therapy

Also known as: oral iron
Oral Iron

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-DeficiencyMenorrhagia

Interventions

Ferrosoferric Oxideferrous sulfateIron

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMineralsMetals, HeavyElementsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 19, 2019

Study Start

February 14, 2020

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)