IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05304442
Phase
PHASE3
Status
Recruiting
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Conditions

  • Anemia, Iron Deficiency
  • Uterine Bleeding

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] — DRUG
    Single Dose of IV Iron
  • Ferrous Sulfate 65 mg elemental iron (325 mg tablets) — DRUG
    Once daily by mouth for 42 days

Study Details

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

Key Dates

Start date
Sep 15, 2022
Status verified
Dec 2024
Primary completion
Mar 31, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous Ferric Derisomaltose
    One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.
  • Active Comparator: Oral Iron
    ferrous sulfate 65 mg once daily for 42 days.

Primary Outcome Measure

mean change in hemoglobin concentration [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ben Taub HospitalHoustonTexas77030
Stephen Boone, MD
[email protected]

Find similar trials in Houston, TX

By research site
Ben Taub Hospital· Houston, TX

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