[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alcea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100650873","non-interventional-study-of-ferretab-comp-ferrous-fumarate--folic-acid-prolonged-release-capsules-effects-in-adult-patients-with-iron-deficiency-anemia-and-cardiovascular-disease-100650873",false,"NCT07753031","Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease","A Multicenter, Non-Interventional, Prospective Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Diseases in Real-World Clinical Practice","PROMETHEUS","Inclusion Criteria:\n\n* Male or female patients aged 18 years or older.\n* Diagnosis of mild to moderate iron deficiency anemia (IDA), defined as hemoglobin 70-129 g\u002FL in men or 70-119 g\u002FL in women and ferritin \\\u003C30 ng\u002FmL, with laboratory results obtained within 14 days before Visit 0.\n* Presence of at least 1 chronic CVD, defined as coronary artery disease or congestive heart failure with preserved ejection fraction (left ventricular ejection fraction ≥50%; NYHA Functional Class I-II).\n* Ability to understand the study requirements and provide written informed consent to participate in the study, including consent for the use and transfer of health information relevant to the study.\n* The physician has decided to prescribe Ferretab® comp. as IDA treatment of IDA at a dose of 2 capsules per day.\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Hypersensitivity to any component of Ferretab® comp.\n* Any contraindication to the use of Ferretab® comp. as specified in the Summary of Product Characteristics.\n* Use of any other iron-containing medicinal products within 3 months prior to study enrollment (including oral iron preparations, intravenous iron formulations, or mineral\u002Fsupplement products containing a therapeutic dose of iron).\n* Severe anemia (hemoglobin concentration \\\u003C70 g\u002FL).\n* Confirmed or suspected diagnosis of anemia of chronic disease.\n* Pregnancy or breastfeeding.\n* Surgery planned to be performed during the study period.\n* CVD or any other chronic disease in the stage of decompensation.\n* Congestive heart failure with reduced ejection fraction (NYHA Functional Class III-IV (see Appendix 2) and\u002For ejection fraction \\\u003C50%).\n* Severe chronic kidney disease (Stage IV-V chronic kidney disease, or patients receiving hemodialysis or peritoneal dialysis).\n* Severe chronic liver disease (Child-Pugh Class B or C liver cirrhosis, active hepatitis, or ALT\u002FAST \\>3 × the upper limit of normal).\n* Active malignancy (patients receiving chemotherapy, radiotherapy, or immunotherapy).\n* Anemias unrelated to iron deficiency, as well as other chronic hematologic disorders (thalassemia, aplastic anemia, myelodysplastic syndrome, and autoimmune hemolytic anemia).\n* Evidence of anemia of inflamation.\n* Gastrointestinal malabsorption disorders (active celiac disease, small bowel resection, short bowel syndrome, or severe flare of Crohn's disease or ulcerative colitis).\n* Recent bleeding, including gastrointestinal bleeding within 3 months before the study entry, surgery associated with blood loss within 8 weeks before the study entry, hemorrhagic stroke within 3 months before the study entry.\n* Blood transfusion within 3 months before the study entry.\n* Severe psychiatric disorders that impair the patient's ability to comply with the Protocol requirements and\u002For to provide valid informed consent.\n* Planned use, at the time of the study entry, of any medication or procedure listed as prohibited therapy.","ALL","18 Years",{"count":20,"type":21},389,"ESTIMATED","12 Weeks","OBSERVATIONAL","The goal of this observational study is to learn how well Ferretab® comp. works and how safe it is for adults with iron deficiency anemia and cardiovascular disease who are receiving treatment as part of their usual medical care. The main questions it aims to answer are:\n\n* Does treatment with Ferretab® comp. improve anemia?\n* Does treatment with Ferretab® comp. improve heart-related symptoms, exercise tolerance, and overall well-being?\n* What side effects do participants have while taking Ferretab® comp.?\n\nThis is a non-interventional study. Participants will receive Ferretab® comp. because their doctor has already decided to prescribe it as part of routine medical care. Ferretab® comp. is an oral medicine that contains iron (as iron fumarate) and folic acid. The study will not change their treatment.\n\nParticipants will:\n\n* Take Ferretab® comp. for 12 weeks as prescribed by their doctor.\n* Attend study visits at the start of treatment, after about 4 weeks, and after about 12 weeks.\n* Have routine blood tests and health assessments during the study.\n* Report any side effects and record information in a patient diary.\n* Answer questions about their symptoms, exercise tolerance, and how easy the treatment is to use.",[26,27,28],"Iron Deficiency Anemia","Coronary Artery Disease","Heart Failure With Preserved Ejection Fraction (HFPEF)",[30,31,32,33,34,35,36,37],"Ferretab® comp.","Ferrous fumarate","Folic acid","Iron replacement therapy","Oral iron therapy","Exercise tolerance","Sideropenic syndrome","Safety of iron therapy","NOT_YET_RECRUITING","2026-08-04",{"date":41,"type":42},"2026-08-07","ACTUAL",{"date":44,"type":21},"2026-09",{"date":46,"type":21},"2027-05",{"name":48,"class":49},"Alcea","OTHER",5,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100605566","phase-3-clinical-study-to-compare-efficacy-and-safety-of-indinol-forto-200-mg-capsules-and-visanne-2-mg-tablets-in-treatment-of-endometriosis-100605566","NCT07164183","Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis","Prospective, Multicenter, Open-label, Randomized, Parallel Groups Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules (LLC Alcea, Russia) and Visanne 2 mg Tablets (BAYER AG, Germany) in Treatment of Endometriosis","Baikal","Inclusion Criteria:\n\n1. The participant provides written informed consent for participation in the study in accordance with current legislation.\n2. Female participants in reproductive\u002Fpremenopausal period from 18 to 45 years old inclusively (at the moment of signing informed consent).\n3. Participants have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis (ICD code #80) within not more than 60 months and not less than 2 weeks of study entry, stage I-III according to endometriosis revised classification of American Fertility Society (R-AFS, 1985)).\n4. Participant has had spontaneous, (i.e., without hormonal therapy) regular, menstrual cycles with a cycle length between 24 to 38 days (inclusive) for the past 2 cycles before Visit 0 and during screening period.\n5. Participant has no current indications for surgical treatment of endometriosis.\n6. Participant has had endometriosis-related pelvic pain assessed with visual analogue scale (VAS) and defined as average daily pain score ≥3.5 cm during 2 menstrual cycles prior to screening (assessed by the participant retrospectively at the moment of screening) and during screening menstrual cycle (according to the data from the participant's diary completed daily).\n7. Presence of other symptoms of endometriosis (e.g. dysmenorrhea, dyspareunia, dyschezia, data of ultrasound imaging, or magnetic resonance imaging (MRI).\n8. The participant agrees to use highly effective contraception methods described in the protocol from the time of signing informed consent through the whole duration of the study and for 2 months after the study completion.\n9. Negative pregnancy test.\n10. Participant completed daily diary on minimum 75% of days during screening menstrual cycle.\n\nExclusion Criteria:\n\n1. Presence of contraindications to Indinol Forto (indolcarbinol)\n2. Presence of contraindications to Visanne (dienogest)\n3. Participant had undiagnosed (unexplained), abnormal, vaginal or urinary tract bleeding within the past 6 months before screening (Visit 0).\n4. Participant has chronic pelvic pain not caused by endometriosis, but other gynecological or urological disorders (consequences of inflammatory process, uterine fibroids, pelvic congestion syndrome, etc.).\n5. Participant has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, fibromyalgia, chronic back pain or chronic headaches).\n6. Endometrioid cysts ≥ 3 cm.\n7. Participant has a surgical history of hysterectomy and\u002For bilateral oophorectomy; premature ovarian failure. Note: Participants who have undergone surgical sterilization (eg, bilateral salpingectomy, tubal ligation) are permitted in the trial.\n8. Participant has a clinically significant gynecologic condition identified in the screening evaluation including, but not limited to, ovarian cysts larger than 3 cm and present longer than 4 months, an active sexually transmitted disease, etc. Note: Participants may be rescreened after completing treatment for infection or for simple ovarian cysts.\n9. Participant with endometriosis-related pelvic pain who didn't respond to previous treatment with combined oral contraceptives, GnRH agonists or antagonist, progestins or aromatase inhibitors. Note: Participants who demonstrated partial response or interrupted their treatment due to side effects, may be enrolled in the study.\n10. History of malignancy, including suspected malignization of endometriomas within ≤5 years before signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n11. Severe renal failure (glomerular filtration rate calculated with Cockcroft-Gault formula is below 30 ml\u002Fmin\u002F1,73 m2).\n12. Systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>90 mm Hg during screening period.\n13. Clinically significantly abnormal laboratory tests at Screening, including: alkaline phosphatase (AP), alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT) \\>200% of the upper limit of normal, or total bilirubin \\>150% of the upper limit of normal; hemoglobin \\\u003C10 g\u002Fdl, white blood cell count \\\u003C2500 in mm³, neutrophil count \\\u003C1500 in mm³, platelet count \\\u003C100 х 10³\u002Fmm³.\n14. Hyperthyroidism (TSH below 0.4 mU\u002FL) or hypothyroidism (TSH above 4.0 mU\u002FL).\n15. Positive pregnancy test (including pregnancy within 3 months prior to screening) or lactation period.\n16. Other medical conditions that, in the judgment of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n17. History of alcohol or substance abuse.\n18. Participation in a clinical study within 90 days before screening.\n19. Other reasons that, in the judgment of the Investigator, may interfere with participation in the study or may lead to unreasonable risks.\n20. Conditions requiring surgery in the period of the study.\n21. Conditions requiring therapy prohibited by the study protocol.","FEMALE","45 Years",{"count":62,"type":21},290,"INTERVENTIONAL",[65],"PHASE3","Prospective open-label randomized parallel groups study to compare efficacy and safety of Indinol Forto® 200 mg capsules and Visanne 2 mg tablets in treatment of endometriosis. This is phase 3 study, based on hypothesis of non-inferiority.",[68],"Endometriosis",[68,70,71,72],"Pelvic pain","Indinol Forto","indole-3-carbinol","RECRUITING","2025-09-12",{"date":76,"type":42},"2025-09-18",{"date":78,"type":42},"2025-09-11",{"date":80,"type":21},"2026-11",{"name":48,"class":49},8,""]