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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 5, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Primary completion date: Oct 2024 to Mar 2025 Completion date: Oct 2024 to Apr 2025v6 Show 1 more changeShow less
    • Completion date: Oct 2024 to Apr 2025
  2. Notable Primary and study completion dates: Dec 2023 to Oct 2024v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Oct 2023 to Dec 2023 · Start date changed from estimate of Sep 2022 to Sep 15, 2022v4 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 2023 to Dec 2023
    • Start date changed from estimate of Sep 2022 to Sep 15, 2022
  4. Notable Primary completion date: Dec 2022 to Oct 2023 Start date: Apr 2022 to Sep 2022 · Completion date: Mar 2023 to Dec 2023v3 Show 2 more changesShow less
    • Start date: Apr 2022 to Sep 2022
    • Completion date: Mar 2023 to Dec 2023
  5. Minor Study description shortened, about 15 wordsv2 See this version in full on ClinicalTrials.gov ↗
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05304442
Lead Sponsor Baylor College of Medicine
Collaborators: Pharmacosmos Therapeutics, Inc.
Conditions Anemia, Iron Deficiency, Uterine Bleeding
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov