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IV Iron Therapy for Uterine Bleeding
Study Summary
This trialmeasures how well different treatments work to treat anemia caused by heavy bleeding in women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I need to be hospitalized for any reason.I am scheduled for a major surgery during the study.I am cleared to leave the emergency department after treatment.I received a blood transfusion during my initial visit.You have had a severe allergic reaction in the past.I am not currently on or recently had blood-related treatment.I weigh less than 50 kg.I am using or will use blood thinners during the study, but not including NSAIDs.Your blood test shows low levels of ferritin, a sign of iron deficiency.I can attend follow-up visits at 3 and 6 weeks.I have recently received IV iron or drugs to increase red blood cell production.I have an active rheumatic disease like rheumatoid arthritis.I do not have a serious infection like pneumonia.I have been experiencing ongoing or repeated uterine bleeding.My kidney function is reduced (eGFR < 60).I have used drugs to help produce red blood cells within the last 8 weeks.You have a known bleeding disorder, and your platelet count is less than 100,000.I have received iron injections within the last 4 weeks.I can be contacted by phone.I am scheduled to receive iron injections or erythropoiesis-stimulating agents.I have heart failure that is moderate to severe.I have been diagnosed with inflammatory bowel disease.I have severe liver disease.You have had a bad reaction to any kind of injected iron before.Your hemoglobin level is lower than 9.0 g/dl, which means you have moderate to severe anemia.
- Group 1: Oral Iron
- Group 2: Intravenous Ferric Derisomaltose
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Intravenous Ferric Derisomaltose?
"The safety of Intravenous Ferric Derisomaltose is vouched for with a score of 3, given the prior clinical proof that supports its efficacy as well as several rounds of data verifying its security."
Is the trial open to individuals under fifty years of age?
"Eligible patients for this trial range between 18 and 65 years old. Nonetheless, there are other studies available to younger or older individuals with 188 trials accommodating those under 18 and 614 for participants over the age of 65."
How many subjects have enrolled in this research initiative?
"Yes, the details available on clinicaltrials.gov state that this medical trial is still soliciting patients - it was initially published on September 15th 2022 and updated most recently on February 6th 2023. It requires 40 individuals to be recruited from 1 location."
Are there any vacancies within this research project for participants?
"Affirmative, the information present on clinicaltrials.gov indicates that this research endeavour is actively seeking participants. It was first posted on September 15th 2022 and last updated February 6th 2023; 40 people are needed from one medical centre."
For whom is enrollment in this experiment accessible?
"This medical trial seeks 40 individuals aged 18 to 65 with iron deficiency anemia. Crucially, the potential candidates should comply with these criteria: serum ferritin not greater than 30 ng/mL; capability for discharge from a hospital emergency department after treatment; ability and willingness to give consent for participation; sub-acute or chronic uterine blood loss; moderate to severe anemia (defined as Hgb no more than 9 g/dl); capacity to return for 3 and 6 week follow-up visits; accessibility by telephone."
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