Last updated 8 days ago
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
372 patients around the world
Available in Brazil
Eurofarma Laboratorios S.A.
1Research sites
372Patients around the world
This study is for people with
Alopecia
Androgenic alopecia
Requirements for the patient
To 60 Years
Male
Medical requirements
- Male participants aged 18 to 60 years at the time of signing the informed consent form.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.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.Willingness to comply with all study procedures and assessments, including permanent scalp tattooing and shaving of the target area.Willingness to maintain hairstyle, hair length, and hair color throughout the study.Willingness to maintain consistent use of hair products and general hair care routine throughout the study.Global scalp photograph obtained at Screening Visit validated centrally prior to randomization.
- 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.History of telogen effluvium within the last 6 months.Presence of other dermatological conditions affecting the scalp, such as seborrheic dermatitis, psoriasis, eczema, or fungal infections.Clinically relevant uncontrolled endocrine disorders that may affect the hair cycle.Uncontrolled thyroid disease.History of autoimmune diseases or collagen vascular diseases.Use of testosterone, its analogues, anabolic steroids, or other systemic androgen therapies within the last 6 months.History of organ transplantation.Physical treatments for hair loss within the last 6 months, such as microneedling, laser therapy, or platelet-rich plasma.History of hair transplantation or use of hairpieces.Severe uncontrolled systemic arterial hypertension or hypotension.History of significant cardiovascular disease, including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III or IV).History or suspicion of pulmonary hypertension associated with mitral stenosis or pheochromocytoma.History of peripheral edema, lymphedema, ascites, or pericardial effusion.Resting tachycardia (heart rate ≥100 bpm).Moderate to severe renal, hepatic, or cardiovascular disease.History of malignancy within the last 5 years, except for successfully treated non-metastatic basal or squamous cell carcinoma of the skin.Current use of potent vasodilators or other prohibited medications.Known allergy or hypersensitivity to minoxidil or any component of the formulation.Hairstyles that may interfere with study assessments, such as permanent braids or dreadlocks.Participants with reproductive potential whose partner does not agree to use effective contraception during the study.Participation in another clinical trial within the last 12 months.Clinically significant laboratory abnormalities at randomization, including HbA1c ≥8%, estimated glomerular filtration rate <45 mL/min, elevated liver enzymes (>2× ULN), abnormal thyroid-stimulating hormone levels, clinically significant ECG abnormalities, hemoglobin <13 g/dL, or hematocrit <39%.
Sites
Eurofarma Laboratorios S.A
StudyMINORA-MEN
SponsorEurofarma Laboratorios S.A.
Study typeInterventional
Conditions
Androgenic alopecia
Requirements
To 60 YearsMale
Unique study IDclinicaltrials.gov
NCT07529977
