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

NCT05304442 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Anemia, Iron Deficiency
  • Uterine Bleeding

Interventions

DRUG

Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]

Single Dose of IV Iron

DRUG

Ferrous Sulfate 65 mg elemental iron (325 mg tablets)

Once daily by mouth for 42 days

Sponsors & Collaborators

  • Pharmacosmos Therapeutics, Inc.

    collaborator UNKNOWN

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-03-31
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304442 on ClinicalTrials.gov