BridgeMD
A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
EU CTIS ID: 2025-522004-24-00
What this study is testing
To determine the efficacy of Sucrosomial® Iron versus Ferric Maltol in achieving the normalization of Hemoglobin (Hb) levels
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Females ≥ 18 years
- Mild anemia (11.0 ≤ Hb < 12 g/dl) or moderate anemia (8.0 < Hb <11 g/dl)
- Signed informed consent form before enrollment
You likely can't join if
- Concomitant use, or in the last month preceding the screening, of other martial drugs or supplements (supplement or drug containing iron).
- History of psychiatric disorders that prevent the expression of informed consent or correct assumption of treatment
- Active cancer disease except for subjects with fibroids and polyps.
- Pregnant or nursing female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females who are not using pharmacological or barrier contraceptive methods (e.g., oral contraceptives, contraceptive patches, intrauterine devices, condoms, or diaphragms). Non-breastfeeding women are not eligible until 6 months after delivery
- Patients participating in another experimental intervention study or receiving another experimental treatment
- History of poor adherence to medical or patient regimes that are considered potentially unreliable and/or uncooperative, unavailable or unable to adhere to the protocol
See the full eligibility criteria
- Females ≥ 18 years
- Mild anemia (11.0 ≤ Hb < 12 g/dl) or moderate anemia (8.0 < Hb <11 g/dl)
- Signed informed consent form before enrollment
- Concomitant use, or in the last month preceding the screening, of other martial drugs or supplements (supplement or drug containing iron).
- History of psychiatric disorders that prevent the expression of informed consent or correct assumption of treatment
- Active cancer disease except for subjects with fibroids and polyps.
- Pregnant or nursing female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females who are not using pharmacological or barrier contraceptive methods (e.g., oral contraceptives, contraceptive patches, intrauterine devices, condoms, or diaphragms). Non-breastfeeding women are not eligible until 6 months after delivery
- Patients participating in another experimental intervention study or receiving another experimental treatment
- History of poor adherence to medical or patient regimes that are considered potentially unreliable and/or uncooperative, unavailable or unable to adhere to the protocol
- Concomitant use of erythropoietin or its use within the three months prior to screening
- Need - from the Investigator's point of view – for transfusion of concentrated erythrocytes and/or for intravenous iron infusion
- Presence of IBD in the phase of severe activity, defined as: HBI index>16 in patients with Crohn's disease and CAI index >12 in patients with ulcerative colitis
- Previous bariatric surgery
- Alcohol abuse
- Hemochromatosis and other iron overload syndromes
- History of hereditary anemia, including thalassemia
- History of hypersensitivity to any ingredients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.