[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616262":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":25,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Eurofarma Laboratorios S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"N1087","EXPERIMENTAL","Participants will receive N1087, starting at 0.5 mg\u002Fday and titrated every 2 weeks (1 mg, 1.5 mg, up to 2 mg\u002Fday) during an 8-week titration period, followed by 16 weeks at the maximum tolerated dose (up to 2 mg\u002Fday). Administered orally once daily for a total of 24 weeks.",[13],"Drug: N1087",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo, administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","N1087 is an oral solution administered in drops. Treatment begins with an 8-week titration period: 0.5 mg\u002Fday for 2 weeks, then 1 mg\u002Fday, 1.5 mg\u002Fday, and up to 2 mg\u002Fday every 2 weeks. After titration, participants continue for 16 weeks at the maximum tolerated dose (up to 2 mg\u002Fday). Administered orally once daily for a total of 24 weeks.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Luiza Terranova","CONTACT","+ 55 11 5090-8421","luiza.terranova@eurofarma.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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",false,"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","18 Years","60 Years",{"count":49,"type":50},372,"ESTIMATED","INTERVENTIONAL",[53],"PHASE3","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.",[56,57],"Female Pattern Hair Loss","Female Pattern Hair Loss, Androgenic Alopecia",[59,60,56,61,62,63],"Androgenetic Alopecia","Hair Loss","Alopecia","Randomized Controlled Trial","Phase 3","NOT_YET_RECRUITING","2026-01-07",{"date":67,"type":68},"2026-01-09","ACTUAL",{"date":70,"type":50},"2027-01",{"date":72,"type":50},"2028-08",{"name":5,"class":6}]