[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eurofarma Laboratorios S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":246},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,77,106,149,171,200,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100633691","phase-3-phase-3-study-to-evaluate-the-efficacy-and-safety-of-oral-minoxidil-n1087-in-men-with-androgenetic-alopecia-100633691",false,"NCT07529977","Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.","A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Male Participants With Androgenetic Alopecia.","MINORA-MEN","Inclusion Criteria:\n\n* Male participants aged 18 to 60 years at the time of signing the informed consent form.\n* Clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 according to the Norwood-Hamilton scale, based on the investigator's clinical assessment.\n* No specific treatment for androgenetic alopecia in the last 6 months, or history of specific treatment for androgenetic alopecia for up to 30 days within the last 6 months.\n* Willingness to comply with all study procedures and assessments, including permanent scalp tattooing and shaving of the target area.\n* Willingness to maintain hairstyle, hair length, and hair color throughout the study.\n* Willingness to maintain consistent use of hair products and general hair care routine throughout the study.\n* Global scalp photograph obtained at Screening Visit validated centrally prior to randomization.\n\nExclusion Criteria:\n\n* Presence of other causes of alopecia, such as alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency-related alopecia, monilethrix, trichotillomania, trichodystrophy, or chemotherapy-induced alopecia.\n* History of telogen effluvium within the last 6 months.\n* Presence of other dermatological conditions affecting the scalp, such as seborrheic dermatitis, psoriasis, eczema, or fungal infections.\n* Clinically relevant uncontrolled endocrine disorders that may affect the hair cycle.\n* Uncontrolled thyroid disease.\n* History of autoimmune diseases or collagen vascular diseases.\n* Use of testosterone, its analogues, anabolic steroids, or other systemic androgen therapies within the last 6 months.\n* History of organ transplantation.\n* Physical treatments for hair loss within the last 6 months, such as microneedling, laser therapy, or platelet-rich plasma.\n* History of hair transplantation or use of hairpieces.\n* Severe uncontrolled systemic arterial hypertension or hypotension.\n* History of significant cardiovascular disease, including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III or IV).\n* History or suspicion of pulmonary hypertension associated with mitral stenosis or pheochromocytoma.\n* History of peripheral edema, lymphedema, ascites, or pericardial effusion.\n* Resting tachycardia (heart rate ≥100 bpm).\n* Moderate to severe renal, hepatic, or cardiovascular disease.\n* History of malignancy within the last 5 years, except for successfully treated non-metastatic basal or squamous cell carcinoma of the skin.\n* Current use of potent vasodilators or other prohibited medications.\n* Known allergy or hypersensitivity to minoxidil or any component of the formulation.\n* Hairstyles that may interfere with study assessments, such as permanent braids or dreadlocks.\n* Participants with reproductive potential whose partner does not agree to use effective contraception during the study.\n* Participation in another clinical trial within the last 12 months.\n* Clinically significant laboratory abnormalities at randomization, including HbA1c ≥8%, estimated glomerular filtration rate \\\u003C45 mL\u002Fmin, elevated liver enzymes (\\>2× ULN), abnormal thyroid-stimulating hormone levels, clinically significant ECG abnormalities, hemoglobin \\\u003C13 g\u002FdL, or hematocrit \\\u003C39%.","MALE","18 Years","60 Years",{"count":21,"type":22},372,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of N1087 compared with placebo in adult men with androgenetic alopecia (male pattern hair loss).\n\nThe study will include male participants aged 18 to 60 years who have a clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 on the Norwood-Hamilton scale. Participants will be randomly assigned, in a 2:1 ratio, to receive either N1087 or placebo. Neither the participants nor the study team will know which treatment each participant receives.\n\nThe study treatment will be taken orally once daily for a total of 24 weeks. During the first 8 weeks, the dose will be gradually increased (titration period) up to a maximum tolerated dose, not exceeding 5 mg. Participants will then continue treatment at the maximum tolerated dose for the remaining 16 weeks.\n\nThe main purpose of the study is to assess whether oral minoxidil improves hair growth. The primary outcome measure is the change from baseline in the density of non-vellus hairs in a defined target area of the scalp (vertex) after 24 weeks of treatment, measured using digital phototrichogram analysis.\n\nSecondary objectives include evaluating changes in hair density at earlier time points, hair thickness, the proportion of terminal hairs, clinical improvement assessed by the investigator, quality of life related to hair loss, and participant satisfaction with treatment.\n\nThe safety and tolerability of oral minoxidil will also be evaluated by monitoring adverse events, vital signs, and events of special interest throughout the study. An independent Data and Safety Monitoring Committee will oversee participant safety during the trial.\n\nThis is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.",[28,29],"Androgenetic Alopecia","Androgenetic Alopecia (AGA)",[31,32,33,34,35,36],"Androgenetic alopecia","Male pattern hair loss","N1087","Hair growth","Phototrichogram","Phase 3 clinical trial","NOT_YET_RECRUITING","2026-04-08",{"date":40,"type":41},"2026-04-14","ACTUAL",{"date":43,"type":22},"2027-01-31",{"date":45,"type":22},"2028-10-30",{"name":47,"class":48},"Eurofarma Laboratorios S.A.","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100616262","phase-3-phase-3-clinical-trial-to-evaluate-the-efficacy-and-safety-of-n1087-in-participants-with-female-pattern-hair-loss-minora-women-100616262","NCT07303322","Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)","Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss","MINORA-WOMEN","Inclusion Criteria:\n\n* Female participants aged ≥18 years and ≤60 years at the time of signing the informed consent form.\n* Presentation of female pattern hair loss in stages 2 to 4 of the Sinclair scale (Women's Alopecia Severity Scale - WASS), based on the Investigator's clinical examination.\n* Absence of specific treatment for female pattern hair loss (FPHL) in the last 6 months or history of specific treatment for FPHL lasting ≤30 days in the last 6 months. Participants currently using specific treatment for FPHL or with prior use lasting \\>30 days in the last 6 months must complete a 3-month washout period before the Randomization Visit (RV).\n* Willing to agree to all procedures and assessments required by the clinical trial, including a permanent tattoo applied to the scalp and shaving of the target area.\n* Willing to maintain hair style, length, and color throughout the study.\n* Willing to maintain consistent use of hair care products and general hair care routine during the entire study.\n\nExclusion Criteria:\n\n* Participant presenting other causes of alopecia, such as: alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency, monilethrix, trichotillomania, trichothiodystrophy, chemotherapy-induced alopecia.\n* Participant who experienced telogen effluvium in the last 6 months, such as after childbirth, infection, intense stress.\n* Participant presenting other dermatological conditions on the scalp, such as: seborrheic dermatitis, psoriasis, eczema, scalp mycosis.\n* Participant presenting signs or symptoms of hyperandrogenism, such as: hirsutism, moderate to severe acne.\n* Participant with previous diagnosis of hormonal disorders, such as: polycystic ovary syndrome, ovarian or adrenal tumors.\n* Participant with previous diagnosis of pituitary disorders, such as: prolactinoma, panhypopituitarism.\n* Participant presenting uncontrolled thyroid disease.\n* Participant with previous diagnosis of autoimmune diseases or collagen disorders, such as: systemic lupus erythematosus, dermatomyositis, scleroderma.\n* Participant in use of hormonal therapy initiated or changed in the last 6 months.\n* Participant who has received an organ transplant.\n* Participant who underwent physical treatments for hair loss in the last 6 months, such as: microneedling, laser, platelet-rich plasma. Note: in this case, the participant must complete a 3-month washout period.\n* Participant with history of hair transplant.\n* Participant who uses hair extensions.\n* Participant presenting severe uncontrolled hypertension (systolic blood pressure \\[SBP\\] \\>180 mmHg or diastolic blood pressure \\[DBP\\] \\>110 mmHg).\n* Participant presenting confirmed orthostatic hypotension (sustained reduction of SBP ≥20 mmHg or DBP ≥10 mmHg within 3 minutes after standing).\n* Participant presenting arterial hypotension (SBP \\\u003C90 mmHg or DBP \\\u003C60 mmHg).\n* Participant with previous diagnosis or suspected pulmonary hypertension associated with mitral stenosis.\n* Participant with previous diagnosis of acute myocardial infarction.\n* Participant with previous diagnosis or suspected pheochromocytoma.\n* Participant presenting history of peripheral edema, lymphedema, or ascites.\n* Participant with history or risk factor for pericardial effusion.\n* Participant with previous diagnosis of other moderate to severe cardiovascular, renal, or hepatic diseases.\n* History of any malignancy in the last 5 years, except successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin.\n* Participant in current use of potent vasodilators, such as: hydralazine and isosorbide.\n* Participant with known allergy or hypersensitivity to minoxidil or any component of the formulation.\n* Participant presenting hair styles that, in the Investigator's opinion, prevent study assessments, such as: permanent braids, dreadlocks, box braids, nagô.\n* Participant who is pregnant, breastfeeding, or has potential to become pregnant and does not agree to use a contraceptive method during the clinical trial.\n* Participant presenting any clinically significant condition that, in the Investigator's opinion, makes the participant unsuitable for participation in the trial.\n* Participant who has participated in clinical trial protocols in the last 12 months, unless the Investigator considers there may be direct benefit.","FEMALE",{"count":21,"type":22},[25],"This is a Phase 3, prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial designed to evaluate the efficacy and safety of N1087 in women with female pattern hair loss (FPHL). Participants will receive either N1087 or placebo for 24 weeks. The study includes a titration period starting at 0.5 mg and increasing up to 2 mg daily, followed by treatment at the maximum tolerated dose. The primary objective is to assess changes in non-vellus hair density in the target scalp area after 24 weeks. Secondary objectives include changes in terminal hair density, hair thickness, global photographic assessment, quality of life, and participant satisfaction. Safety will be monitored through adverse events, vital signs, and laboratory tests. Approximately 372 participants will be randomized in a 2:1 ratio (N1087 vs. placebo) across about 10 research centers in Brazil.",[62,63],"Female Pattern Hair Loss","Female Pattern Hair Loss, Androgenic Alopecia",[28,65,62,66,67,68],"Hair Loss","Alopecia","Randomized Controlled Trial","Phase 3","2026-01-07",{"date":71,"type":41},"2026-01-09",{"date":73,"type":22},"2027-01",{"date":75,"type":22},"2028-08",{"name":47,"class":48},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100617417","phase-3-study-of-formoterol-6-mcgfluticasone-125-mcg-by-eurofarma-laboratrios-sa-versus-alenia-6-mcg200-mcg-in-patients-with-asthma-forasma-100617417","NCT07318350","Study of Formoterol 6 mcg\u002FFluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg\u002F200 mcg in Patients With Asthma (FORASMA)","Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg \u002F Budesonide 200 mcg) in the Treatment of Moderate Asthma","FORASMA","Inclusion Criteria:\n\n* Age ≥ 12 and ≤ 65 years at Screening.\n* History of recurrent asthma symptoms (cough, wheezing, shortness of breath, chest tightness).\n* Previous medical diagnosis of asthma (confirmed by records, prescriptions, or participant report).\n* Documented reversible airway obstruction by spirometry: FEV₁ increase ≥ 200 mL and ≥ 12% post-bronchodilator (at screening or prior report).\n* Moderate asthma (GINA step 3) for ≥ 6 months, clinically stable and controlled with LABA + low-dose inhaled corticosteroid for ≥ 90 days.\n* ACQ-7 score ≤ 0.75 at Screening.\n* At Randomization: ACQ-7 score ≤ 0.75 and ≥ 70% adherence during run-in.\n\nExclusion Criteria:\n\n* Moderate\u002Fsevere asthma exacerbation within 90 days prior to screening.\n* Other pulmonary disease (including predominant COPD).\n* Symptomatic acute or chronic respiratory infection.\n* BMI ≥ 40 kg\u002Fm².\n* Use of LAMA within 6 months prior to screening.\n* Oral or depot corticosteroids within 30 days prior to screening.\n* Biologic therapy for asthma, allergic rhinitis, or urticaria within 12 months prior to screening.\n* Systemic vasoconstrictors within 7 days prior to screening.\n* Known hypersensitivity to formoterol, fluticasone, budesonide, or any component of study drugs.\n* Active pulmonary tuberculosis or fungal airway infection.\n* History or presence of ischemic heart disease, severe arrhythmias, cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, QTc \\> 450 ms.\n* History of hyperthyroidism or uncontrolled diabetes mellitus.\n* Severe or uncontrolled disease at investigator's discretion.\n* Pregnancy or breastfeeding; women of childbearing potential not using effective contraception.\n* Participation in another clinical trial within 12 months unless direct benefit expected.\n* Any condition making participant unsuitable for study per investigator.\n* At Randomization: asthma exacerbation during run-in, prohibited medication use, HbA1c ≥ 10%, TSH below normal, ALT or AST \\> 2× ULN, serum potassium below normal, severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²), clinically significant ECG changes or QTc \\> 450 ms, or any abnormality making participant unsuitable.","ALL","12 Years","65 Years",{"count":89,"type":22},174,[25],"This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg \u002F Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.",[93],"Moderate Asthma",[95,93,96,97,98,68],"Asthma","Alenia®","Non-inferiority","Randomized Clinical Trial","2026-01-05",{"date":69,"type":41},{"date":102,"type":22},"2026-10",{"date":104,"type":22},"2028-09",{"name":47,"class":48},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":57,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100585657","phase-3-study-of-new-antiandrogenic-progestogen--low-dose-estrogen-for-moderate-acne-vulgaris-100585657","NCT06905210","Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris","Phase III Superiority, Randomized, Double-blind, Placebo-controlled, Adaptive, Multicenter Study to Compare the Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-dose Estrogen for the Treatment of Moderate Acne Vulgaris","PANDORA","Inclusion Criteria:\n\n1. Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form (ITA), if applicable, prior to any procedure provided for in the protocol. Note: The adult participant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trial procedures. The adolescent participant must provide assent by signing the ITA based on local regulations and\u002For guidelines prior to the start of any study procedures.\n2. Female sex.\n3. Age between 14 and 45 years (inclusive).\n4. At least one year after menarche.\n5. At least one menstrual period during the last 03 months.\n6. Absence of known contraindications for the use of combined oral contraceptives. 7. Diagnosis of moderate acne vulgaris on the face for at least six months, characterized by the presence of:\n\nNote: Information regarding the duration of the disease can be obtained from the clinical history reported by the participant or from a brief medical report of the participant's history, if she is referred from another service.\n\n1. At least 15 inflammatory lesions (papules or pustules);\n2. At least 10 non-inflammatory lesions (comedones); and\n3. Up to 03 small inactive nodules. Note: Nodules are lesions between 10 and 30 mm, more palpable than visible.\n\n   8\\. Classification ≥ 3 on the 6-point scale of the Investigator's Static Global Assessment (ISGA).\n\n   9\\. When the participant did not obtain adequate results with topical treatment, failure or impossibility of systemic treatment with antibiotics (contraindications or intolerance) and the patient has an indication for the use of antiandrogens and\u002For isotretinoin.\n\n   10\\. Agreement not to use other topical and\u002For systemic treatments for acne during the study.\n\nExclusion Criteria:\n\n1\\. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use non-hormonal contraceptive methods permitted during the study, unless they are surgically sterile or who expressly declare themselves to be free from risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.\n\n4\\. Current or previous treatment with agents described below with a washout period shorter than that provided for each:\n\n1. At least 6 months for systemic isotretinoin and\u002For injectable contraceptive (such as Depo Provera);\n2. At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);\n3. At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);\n4. At least 4 weeks for topical retinoids;\n5. At least 2 weeks for other topical anti-acne agents (such as topical antibiotics or benzoyl peroxide); 5. Personal history or first-degree family history of vascular disease including previous arterial thromboembolic disease (myocardial infarction or stroke), venous thromboembolic disease (peripheral venous thrombosis or pulmonary embolism) or any condition that increases the risk for any of the previous conditions.\n\n   6\\. Known personal history of thrombophilia. 7. Current smoking. 8. Any disease or condition that compromises the function of body systems that would result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication, including malabsorptive conditions (such as previous bariatric surgery).\n\n   9\\. Any condition that worsens under hormonal treatment or that interferes with the conduct of the study or interpretation of the results, such as gestational herpes or idiopathic jaundice during previous pregnancy, otosclerosis, Sydeham's chorea, porphyria, bile flow disorders (presence or history of cholestasis, gallstones, systemic lupus erythematosus).\n\n   10\\. Other comorbidities (history or current diagnosis) such as chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma with chronic use of oral corticosteroids, multiple sclerosis, Chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, vascular complications of diabetes, major depressive disorder or other conditions that, in the investigator's assessment, may compromise the participant's safety.\n\n   11\\. Hypersensitivity to any of the components of the experimental drug or placebo.\n\n   12\\. Presence of moderate to severe atopy, acne comedonica or acne conglobata, induced acne or acne with multiple large nodules, cysts, fistular comedones or fistular duct abscess or other dermatological conditions that, in the investigator's assessment, may compromise the evaluation of efficacy.\n\n   13\\. Use of comedogenic creams or sunscreens, other preparations with sex hormones or any other anti-acne therapy (such as phototherapy, oleic acids, chemical peeling, mechanical extraction of comedones).\n\n   14\\. Preparations with acnegenic effects, such as iodinated or brominated drugs, tuberculostatics, lithium, vitamins B1 (\\> 1.5 mg\u002Fday), B6 (\\> 2 mg\u002Fday) or B12 (\\> 6 g\u002Fday), corticosteroids, adrenocorticotropic hormone (ACHT), anabolic steroids, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, certain oily cosmetics.\n\n   15\\. History of drug abuse. 16. History of neoplasia in the last 5 years, except non-melanoma skin cancer, or any history of sex hormone-dependent neoplasia or current suspicion of neoplasia, including meningioma.\n\n   17\\. Use of other medications that interfere with hepatic metabolism via cytochrome P450, such as carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, rifampicin, ritonavir and products containing St. John's wort.\n\n   18\\. Use of direct-acting antiviral medications containing ombitasvir, paritaprevir or dasabuvir and combinations of these medications.\n\n   19\\. Undiagnosed vaginal bleeding. 20. Change in clinical breast examination or other clinically significant finding on gynecological examination that could, in the opinion of the investigator, be worsened by oral contraceptives. 21. Absence of proof of a Pap smear (oncotic cytology) without changes suspicious of malignancy in the last 12 months. Note: If the participant does not have a previous exam within the accepted interval and agrees, the exam may be performed at the Selection Visit (VS\u002FV1).\n\n   22\\. Absence of proof of a bilateral mammogram without changes suspicious of malignancy in the last 12 months, only for participants aged ≥ 40 years. Note: Mammograms with suspicious of malignancy are considered 23. Obesity (BMI \\> 30 kg\u002Fm²). 24. Uncontrolled arterial hypertension (Systolic Blood Pressure \\[SBP\\] ≥140 mmHg or Diastolic Blood Pressure \\[DBP\\] ≥ 90 mmHg).\n\n   25\\. Participant who has participated in clinical trial protocols in the last 12 (twelve) months, unless the investigator believes that there may be direct benefit to the participant.\n\n   26\\. Participant who, in the opinion of the investigator, presents other clinical or laboratory conditions or alterations that make him\u002Fher unfit to participate in the study","14 Years","45 Years",{"count":117,"type":22},526,[25],"This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab\u002Fultrasound exams.",[121,122],"Acne Vulgaris","Acne Vulgaris on the Face",[124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"Acne treatment","fixed-dose combination","moderate acne","randomized controlled trial","women's dermatology","adaptive clinical study","efficacy & safety evaluation","hormonal acne research","Moderate acne vulgaris","Phase III","Randomized","Double-blind","Placebo-controlled","Adaptive design","Multicenter","Superiority trial","2025-04-01",{"date":142,"type":41},"2025-04-04",{"date":144,"type":22},"2026-03",{"date":146,"type":22},"2027-03",{"name":47,"class":48},1,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":85,"minAge":157,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":148},"100534093","phase-3-study-of-fluticasoneformoterolglycopyrronium-for-the-treatment-chronic-obstructive-pulmonary-disease-triplar-100534093","NCT06234345","Study of Fluticasone\u002FFormoterol\u002FGlycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)","Randomized, Open-label, Parallel, Active-controlled, Multicenter Study of Efficacy and Safety of Fixed-dose Combination of Fluticasone \u002FFormoterol \u002FGlycopyrronium for the Treatment of Patients with Chronic Obstructive Pulmonary Disease","TRIPLAR","Inclusion Criteria:\n\n* Participants of both sexes who meet all of the following criteria will be included in the study:\n\n  1. Signed Informed Consent Form (ICF).\n  2. Male or female aged 40 or over.\n  3. Medical diagnosis of chronic obstructive pulmonary disease (COPD) documented by post-bronchodilator FEV1\u002FFVC (Forced Expiratory Volume in the 1st second\u002F Forced Vital Capacity) ratio \\\u003C 0.7 (Previous examination report or examination performed at the screening visit).\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Pregnant or lactating women.\n  2. Current diagnosis of asthma without current diagnosis of chronic obstructive pulmonary disease (COPD). Observation: Subjects with a prior history of asthma are eligible if they have a current diagnosis of chronic obstructive pulmonary disease (COPD).\n  3. Other respiratory disorders other than chronic obstructive pulmonary disease (COPD) (for example, but not restricted to: active tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension).","40 Years",{"count":159,"type":22},1252,[25],"Several studies have demonstrated the benefits of the LAMA (Long-Acting Muscarinic Antagonists) + LABA (Long-Acting Beta-Agonists) + IC (inhaled corticosteroids) combination in the treatment of chronic obstructive pulmonary disease (COPD). The use of the triple combination in patients with severe airflow obstruction and a history of flares has been associated with improved lung function, improved patient-reported endpoints and prevention of flares, when compared to LABA, LABA + LAMA and LABA + IC. Furthermore, when compared to dual therapies LABA + IC and LABA + LAMA, triple therapy has been able to reduce all-cause deaths among chronic obstructive pulmonary disease (COPD) patients.\n\nPreviously published studies have demonstrated that the triple combination of Fluticasone 250 mcg\u002FFormoterol 12 mcg\u002FGlycopyrronium 12.5 mcg was able to improve lung function in chronic obstructive pulmonary disease (COPD) patients with a history of flares. There was also a significant improvement in the mMRC (modified-Medical Research Council) which began in the 2nd week of treatment and continued up to week 12. The association was considered safe and well tolerated, with only mild to moderate adverse events recorded in approximately 25% of the subjects treated in the study.\n\nFurthermore, bioavailability studies performed with the components of the combination proposed as experimental drug - Fluticasone\u002FFormoterol\u002FGlycopyrronium - indicated that there is no pharmacokinetic interaction between the 3 active ingredients when they were administered concomitantly to healthy individuals under fasting conditions.",[163],"Chronic Obstructive Pulmonary Disease","2025-02-13",{"date":166,"type":41},"2025-02-14",{"date":168,"type":22},"2026-09",{"date":75,"type":22},{"name":47,"class":48},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":179,"sex":85,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":148},"100573913","evaluation-of-the-ef192b-protection-versus-no-treatment-100573913","NCT06752460","Evaluation of the EF192B Protection Versus No Treatment","Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment","Spray B","Inclusion criteria\n\n* Age between 18 and 70 years old.\n* Fitzpatrick skin phototype classification I to IV.\n* Presence of intact skin in the test region (right forearm and left forearm for selected participants).\n* Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.\n* Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.\n\nExclusion Criteria\n\n* Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.\n* Diagnosis of immunological insufficiency.\n* Use of systemic corticosteroids or immunosuppressants.\n* Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and\u002For hyperosmolar coma.\n* History of reaction to liquid dressings.\n* Known hypersensitivity to any ingredients of investigational product formulation.\n* Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.\n* Presence of any serious or uncontrolled diseases, at the investigator's discretion.\n* Pregnancy or lactation.\n* Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.\n* Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.",true,"70 Years",{"count":182,"type":22},72,[184],"NA","This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.",[187,188],"Skin Lesions","Skin Care",[190,191],"effectiveness","Contact test","2024-12-20",{"date":194,"type":41},"2024-12-30",{"date":196,"type":22},"2025-08-31",{"date":198,"type":22},"2025-10-31",{"name":47,"class":48},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":85,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":148},"100562846","phase-3-fixed-dose-combination-of-an-angiotensin-receptor-blocker-and-thiazide-diuretic-for-essential-hypertension-100562846","NCT06608472","Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension","A Phase III, Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, Efficacy and Safety Study of a New Fixed-dose Combination of an Angiotensin Receptor Blocker and a Thiazide Diuretic for the Treatment of Essential (primary) Arterial Hypertension","ATHESA","Inclusion Criteria:\n\n1. Ability to confirm voluntary participation and agree to all purposes of the study, signing and dating the Informed Consent Form in two copies.\n2. Age ≥ 18 years.\n3. Medical office blood pressure with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg without pharmacological treatment or which is not adequately controlled with monotherapy or with a combination of two drugs in which at least one of the drugs is not at the maximum dose.\n4. Uncontrolled arterial hypertension (medical office BP with SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) after at least two (02) weeks of run-in treatment.\n5. Compliance with run-in treatment ≥ 80% and ≤ 120%.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Women in the reproductive age or of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or expressly declare themselves to be free from the risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.\n3. Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.\n4. Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\\'s syndrome).\n5. Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and\u002For Chronic Kidney Disease stage IV or V.\n6. History of hypertensive emergencies in the last 6 months.\n7. Moderate to severe cardiovascular (acute myocardial infarction or unstable angina, unstable or life-threatening arrhythmia) and\u002For cerebrovascular events within the last 6 months or any other disorder that in the opinion of the investigator excludes the participant from the study.\n8. Participant who is unwilling to switch from hypertension treatment to study medications.\n9. 12-lead electrocardiogram (ECG) with any clinically significant abnormality.\n10. Drug or alcohol abuse in the last 2 years.\n11. Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.",{"count":209,"type":22},292,[25],"This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.",[213],"Essential Arterial Hypertension",[215,216],"hypertension","blood pressure","2024-11-26",{"date":219,"type":41},"2024-11-27",{"date":221,"type":22},"2026-11-30",{"date":223,"type":22},"2029-10-30",{"name":47,"class":48},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":157,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":245,"locationsCount":148},"100558101","phase-3-efficacy-and-safety-of-two-fixed-dose-combinations-in-men-with-lower-urinary-tract-symptoms-associated-with-benign-prostatic-hyperplasia-benipro-100558101","NCT06546735","Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)","Randomized, Double-blind, Double-masked, Parallel-group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.","BENIPRO","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all purposes of the trial by signing and dating the Informed Consent Form in two copies.\n* Men ≥40 years of age.\n* History of overactive bladder symptoms (urinary frequency and urgency with or without urinary incontinence) and LUTS for at least 3 months due to BPH.\n* History of urinary symptoms (≥1 urgency\u002F24-hour episode and ≥8 urination\u002F24-hour) for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* Participant who has received mirabegrone or antimuscarinics for the treatment of LUTS within the last 30 days prior to the Screening Visit.\n* Participant with evidence of lower urinary tract infection (UTI), confirmed by a culture \\>100,000 CFU\u002FmL. Should a participant present with a UTI at screening, they may be screened again after successful UTI treatment (confirmed by negative urine culture).\n* Participant with symptomatic UTI, prostatitis, or chronic inflammation (such as interstitial cystitis, bladder stones, prior pelvic radiation therapy, or previous or current malignancy within the boundaries of the pelvis, including bladder, prostate, and rectum).\n* History of recurrent UTI (2 episodes in the last 6 months or 3 episodes in the last year).\n* Participant who has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.).\n* Participant with a previous diagnosis of diabetic neuropathy.\n* History of previous open, robotic, or minimally invasive prostate surgery (including transurethral procedures), or reconstructive bladder surgery.\n* Participant with planned pelvic or prostate surgery during the trial period.\n* Participant with planned cataract or glaucoma surgery during the trial period.\n* Participant with significant stress incontinence or post-surgical prostate incontinence as determined by the Investigator.",{"count":234,"type":22},816,[25],"The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages, such as better adherence to treatment. The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists.",[238],"Benign Prostatic Hyperplasia with Lower Urinary Tract Symptoms","2024-11-13",{"date":241,"type":41},"2024-11-15",{"date":221,"type":22},{"date":244,"type":22},"2028-08-30",{"name":47,"class":48},""]