IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
Recruiting
Phase 3
Interventional Study
Anemia, Iron Deficiency
Uterine Bleeding
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Baylor College of Medicine · Other
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About This Trial
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 Locations
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Eligibility Criteria
Inclusion Criteria:
* Sub-acute or chronic uterine blood loss;
* Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;
* Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;
* Eligible for discharge from the ED following treatment;
* Patient able to return for planned…
Contacts