Androgenetic AlopeciaPhase 3MINORA-MENNCT07529977
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
A Phase 3 study testing Minoxidil oral solution in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by Eurofarma Laboratorios S.A..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- What is being tested?
- Minoxidil oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2027to 30 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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%.
About this study
Official title: 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.
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).
The 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.
Read more
The 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.
The 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.
Secondary 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.
The 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.
This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.
- Conditions
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Being tested
- Minoxidil oral solution, Placebo oral solution
- Keywords
- Androgenetic alopecia, Male pattern hair loss, N1087, Hair growth, Phototrichogram, Phase 3 clinical trial
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil oral solutionDrug
Minoxidil 5 mg/mL oral solution administered once daily. Treatment includes a dose titration period starting at 0.75 mg and gradually increasing to 1.25 mg, 2.5 mg, and up to a maximum dose of 5 mg or the maximum tolerated dose. The titration period lasts 8 weeks, followed by maintenance at the maximum tolerated dose through Week 24.
Placebo oral solutionDrug
Placebo oral solution drops administered once daily. The placebo follows the same dose titration schedule and treatment duration as the experimental intervention, for a total treatment duration of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| N1087 | Experimental | Not described Receives: Drug: Minoxidil oral solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in non-vellus hair density in the target area of the scalp (vertex)
Change from baseline in the density of non-vellus hairs (≥ 0.03 mm in diameter) in the target area of the scalp (vertex) after 24 weeks of treatment, expressed as hairs per square centimeter (hairs/cm²). Hair density is assessed using digital phototrichogram analysis.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start31 Jan 2027 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529977
- Sponsor's protocol ID
- EF193B
- Acronym
- MINORA-MEN
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07529977
- Acronym / sponsor ID
- MINORA-MEN / EF193B
- Conditions
- Androgenetic Alopecia, Androgenetic Alopecia (AGA)
- Keywords
- Androgenetic alopecia, Male pattern hair loss, N1087, Hair growth, Phototrichogram, Phase 3 clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
The 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.
The 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.
The 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.
Secondary 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.
The 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.
This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N1087 | Experimental | Drug: Minoxidil oral solution |
| Placebo | Placebo comparator | Drug: Placebo oral solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minoxidil oral solutionMinoxidil 5 mg/mL oral solution administered once daily. Treatment includes a dose titration period starting at 0.75 mg and gradually increasing to 1.25 mg, 2.5 mg, and up to a maximum dose of 5 mg or the maximum tolerated dose. The titration period lasts 8 weeks, followed by maintenance at the maximum tolerated dose through Week 24. | Drug | N1087 |
| Placebo oral solutionPlacebo oral solution drops administered once daily. The placebo follows the same dose titration schedule and treatment duration as the experimental intervention, for a total treatment duration of 24 weeks. | Drug | Placebo |
Primary outcome
Change from baseline in non-vellus hair density in the target area of the scalp (vertex)
Time frame: Baseline to Week 24
Change from baseline in the density of non-vellus hairs (≥ 0.03 mm in diameter) in the target area of the scalp (vertex) after 24 weeks of treatment, expressed as hairs per square centimeter (hairs/cm²). Hair density is assessed using digital phototrichogram analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minoxidil oral solution in people with Androgenetic Alopecia and Androgenetic Alopecia (AGA), run by Eurofarma Laboratorios S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in non-vellus hair density in the target area of the scalp (vertex) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.