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IV vs Oral Iron for Anemia Due to Heavy Menstrual Bleeding
Study Summary
This trial is studying whether intravenous (IV) iron is better than oral iron pills for correcting anemia in women who have heavy menstrual bleeding and anemia.
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.Side effects data
From 2017 Phase 4 trial • 296 Patients • NCT01227616Trial Design
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Who is running the clinical trial?
Media Library
- I experience heavy menstrual bleeding that bothers me.I have sickle cell disease.I need a blood transfusion or urgent surgery for my severe anemia.Your hemoglobin level is lower than 11.5 grams per deciliter.I am not allergic to the study drug.You have too much iron in your body.I am a woman aged between 18 and 50.I have or might have cancer.
- Group 1: Oral Iron
- Group 2: IV Iron
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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
To what extent have other research initiatives explored the effects of intravenous iron?
"Presently, there are 35 trials being conducted to investigate Intravenous Iron therapy. Of those active investigations, 7 have reached Phase 3 status. The majority of these clinical studies are taking place in Kano and Lagos, although a total of 154 sites across the globe hold research for this treatment option."
What indications typically call for intravenous iron infusion?
"Intravenous Iron is typically administered to lactating mothers. It can also be used in cases of folic acid deficiency, iron insufficiency, and nutritional supplementing needs."
To what type of patient is enrollment in this trial appropriate?
"Qualifying conditions for enrollment in this trial are menorrhagia and a patient age between 18-55. A total of 76 participants need to be recruited."
Is the enrollment cutoff age for this clinical trial greater than 35 years old?
"As specified in the inclusion criteria, only those aged between 18 and 55 may apply to this medical trial. There are 171 studies geared towards patients younger than 18 years old, while 488 investigate treatments for people above 65."
What potential risks accompany intravenous iron infusions?
"IV Iron has been approved and is thus rated at a 3 on our scale. This indicates that multiple rounds of data have validated its safety level."
Are there currently spaces available for participation in this clinical research?
"Affirmative. The information accessible on clinicaltrials.gov unveils that this medical research is actively seeking out eligible participants, with an initial posting date of February 14th 2020 and a recent update on October 18th 2022. 76 patients are needed for the experiment at one particular site."
What is the total sample size of this experiment?
"Affirmative. Evidence on clinicaltrials.gov shows that this research project, which was published in February 2020, is actively seeking participants. Specifically, the team needs 76 individuals to register from one single medical location."
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