Female Pattern Hair LossPhase 3MINORA-WOMENNCT07303322
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
A Phase 3 study testing N1087 in people with Female Pattern Hair Loss and Female Pattern Hair Loss, Androgenic Alopecia, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
- What is being tested?
- N1087
- 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
- 1 siteBrazil
- Study dates
- Jan 2027to Aug 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged ≥18 years and ≤60 years at the time of signing the informed consent form.
- 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.
- 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).
- 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.
- Willing to maintain hair style, length, and color throughout the study.
- Willing to maintain consistent use of hair care products and general hair care routine during the entire study.
Who cannot join
- Participant presenting other causes of alopecia, such as: alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency, monilethrix, trichotillomania, trichothiodystrophy, chemotherapy-induced alopecia.
- Participant who experienced telogen effluvium in the last 6 months, such as after childbirth, infection, intense stress.
- Participant presenting other dermatological conditions on the scalp, such as: seborrheic dermatitis, psoriasis, eczema, scalp mycosis.
- Participant presenting signs or symptoms of hyperandrogenism, such as: hirsutism, moderate to severe acne.
- Participant with previous diagnosis of hormonal disorders, such as: polycystic ovary syndrome, ovarian or adrenal tumors.
- Participant with previous diagnosis of pituitary disorders, such as: prolactinoma, panhypopituitarism.
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- Participant presenting uncontrolled thyroid disease.
- Participant with previous diagnosis of autoimmune diseases or collagen disorders, such as: systemic lupus erythematosus, dermatomyositis, scleroderma.
- Participant in use of hormonal therapy initiated or changed in the last 6 months.
- Participant who has received an organ transplant.
- 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.
- Participant with history of hair transplant.
- Participant who uses hair extensions.
- Participant presenting severe uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >110 mmHg).
- Participant presenting confirmed orthostatic hypotension (sustained reduction of SBP ≥20 mmHg or DBP ≥10 mmHg within 3 minutes after standing).
- Participant presenting arterial hypotension (SBP <90 mmHg or DBP <60 mmHg).
- Participant with previous diagnosis or suspected pulmonary hypertension associated with mitral stenosis.
- Participant with previous diagnosis of acute myocardial infarction.
- Participant with previous diagnosis or suspected pheochromocytoma.
- Participant presenting history of peripheral edema, lymphedema, or ascites.
- Participant with history or risk factor for pericardial effusion.
- Participant with previous diagnosis of other moderate to severe cardiovascular, renal, or hepatic diseases.
- History of any malignancy in the last 5 years, except successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin.
- Participant in current use of potent vasodilators, such as: hydralazine and isosorbide.
- Participant with known allergy or hypersensitivity to minoxidil or any component of the formulation.
- Participant presenting hair styles that, in the Investigator's opinion, prevent study assessments, such as: permanent braids, dreadlocks, box braids, nagô.
- Participant who is pregnant, breastfeeding, or has potential to become pregnant and does not agree to use a contraceptive method during the clinical trial.
- Participant presenting any clinically significant condition that, in the Investigator's opinion, makes the participant unsuitable for participation in the trial.
- Participant who has participated in clinical trial protocols in the last 12 months, unless the Investigator considers there may be direct benefit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taís Mendonça dos Santos contact
Brazil1 site
Eurofarma Laboratórios S.A
Itapevi, São Paulo, 06696-000
Natalia Silva Di Gianni, +55 11 4144-9500, natalia.gianni@eurofarma.com
Taís Mendonça dos Santos, tais.santos@eurofarma.com
About this study
Official title: 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
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.
Read the detailed description
This Phase 3 clinical trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of N1087 in women with female pattern hair loss (FPHL), also known as female androgenetic alopecia. FPHL is a chronic, progressive condition characterized by gradual thinning of hair and reduced density, primarily in the frontal and vertex regions of the scalp. Current treatment options are limited, and topical minoxidil, although widely used, is not approved for women in Brazil and presents adherence challenges. Low-dose oral minoxidil has shown promising efficacy and safety in clinical practice and literature, but high-quality controlled trials are lacking.
Participants will be randomized in a 2:1 ratio to receive N1087 or placebo for 24 weeks. The intervention begins with an 8-week titration period (0.5 mg/day for 2 weeks, then 1 mg, 1.5 mg, and 2 mg every 2 weeks) followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). The primary endpoint is the change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target area at Week 24, assessed by standardized digital phototrichogram. Secondary endpoints include changes in terminal hair density, total hair density, hair shaft thickness, reversal of follicular miniaturization, global photographic assessment (Investigator Global Assessment), quality of life (WAA-QoL questionnaire), and participant satisfaction. Safety assessments include adverse events, vital signs, ECG, and laboratory tests.
The study will enroll approximately 372 participants across 10 sites in Brazil, with eligibility criteria including women aged 18-60 years, Sinclair scale 2-4, and no recent treatments for FPHL. Exclusion criteria include other causes of alopecia, uncontrolled hypertension, cardiovascular conditions, hormonal disorders, and pregnancy. The total study duration per participant is approximately 36 weeks (up to 12 weeks screening/washout, 8 weeks titration, 16 weeks treatment). A Data Monitoring Committee will oversee safety.
- Being tested
- N1087, Placebo
- Keywords
- Androgenetic Alopecia, Hair Loss, Female Pattern Hair Loss, Alopecia, Randomized Controlled Trial, Phase 3
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1087Drug
N1087 is an oral solution administered in drops. Treatment begins with an 8-week titration period: 0.5 mg/day for 2 weeks, then 1 mg/day, 1.5 mg/day, and up to 2 mg/day every 2 weeks. After titration, participants continue for 16 weeks at the maximum tolerated dose (up to 2 mg/day). Administered orally once daily for a total of 24 weeks.
PlaceboDrug
Placebo administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| N1087 | Experimental | Participants will receive N1087, starting at 0.5 mg/day and titrated every 2 weeks (1 mg, 1.5 mg, up to 2 mg/day) during an 8-week titration period, followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). Administered orally once daily for a total of 24 weeks. Receives: Drug: N1087 |
| 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. Receives: Drug: Placebo |
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 (≥0.03 mm diameter) in the target scalp area at Week 24
Non-vellus hair density (≥0.03 mm diameter) will be measured in the target scalp area using standardized digital phototrichogram. The primary endpoint is the absolute change from baseline to Week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies 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
- Model description
- Participants will be randomized 2:1 to receive N1087 or placebo. The intervention includes an 8-week dose titration (0.5 mg, 1 mg, 1.5 mg, 2 mg, each for 2 weeks), followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). Randomization will be stratified by Sinclair scale (2-4) and age (\<40 or ≥40). Multicenter, Brazil.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT07303322
- Sponsor's protocol ID
- EF193A
- Acronym
- MINORA-WOMEN
- Status last verified
- Nov 2026
- First submitted
- 11 Dec 2025
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07303322
- Acronym / sponsor ID
- MINORA-WOMEN / EF193A
- Keywords
- Androgenetic Alopecia, Hair Loss, Female Pattern Hair Loss, Alopecia, Randomized Controlled Trial, Phase 3
- 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
- Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Dec 2025 (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 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.
Detailed description
This Phase 3 clinical trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of N1087 in women with female pattern hair loss (FPHL), also known as female androgenetic alopecia. FPHL is a chronic, progressive condition characterized by gradual thinning of hair and reduced density, primarily in the frontal and vertex regions of the scalp. Current treatment options are limited, and topical minoxidil, although widely used, is not approved for women in Brazil and presents adherence challenges. Low-dose oral minoxidil has shown promising efficacy and safety in clinical practice and literature, but high-quality controlled trials are lacking.
Participants will be randomized in a 2:1 ratio to receive N1087 or placebo for 24 weeks. The intervention begins with an 8-week titration period (0.5 mg/day for 2 weeks, then 1 mg, 1.5 mg, and 2 mg every 2 weeks) followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). The primary endpoint is the change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target area at Week 24, assessed by standardized digital phototrichogram. Secondary endpoints include changes in terminal hair density, total hair density, hair shaft thickness, reversal of follicular miniaturization, global photographic assessment (Investigator Global Assessment), quality of life (WAA-QoL questionnaire), and participant satisfaction. Safety assessments include adverse events, vital signs, ECG, and laboratory tests.
The study will enroll approximately 372 participants across 10 sites in Brazil, with eligibility criteria including women aged 18-60 years, Sinclair scale 2-4, and no recent treatments for FPHL. Exclusion criteria include other causes of alopecia, uncontrolled hypertension, cardiovascular conditions, hormonal disorders, and pregnancy. The total study duration per participant is approximately 36 weeks (up to 12 weeks screening/washout, 8 weeks titration, 16 weeks treatment). A Data Monitoring Committee will oversee safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 2:1 to receive N1087 or placebo. The intervention includes an 8-week dose titration (0.5 mg, 1 mg, 1.5 mg, 2 mg, each for 2 weeks), followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). Randomization will be stratified by Sinclair scale (2-4) and age (<40 or ≥40). Multicenter, Brazil.
| Arm | Type | Receives |
|---|---|---|
| N1087 | Experimental | Drug: N1087Participants will receive N1087, starting at 0.5 mg/day and titrated every 2 weeks (1 mg, 1.5 mg, up to 2 mg/day) during an 8-week titration period, followed by 16 weeks at the maximum tolerated dose (up to 2 mg/day). Administered orally once daily for a total of 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo, administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged ≥18 years and ≤60 years at the time of signing the informed consent form.
- 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.
- 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).
- 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.
- Willing to maintain hair style, length, and color throughout the study.
Key exclusion criteria (29 listed)
- Participant presenting other causes of alopecia, such as: alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency, monilethrix, trichotillomania, trichothiodystrophy, chemotherapy-induced alopecia.
- Participant who experienced telogen effluvium in the last 6 months, such as after childbirth, infection, intense stress.
- Participant presenting other dermatological conditions on the scalp, such as: seborrheic dermatitis, psoriasis, eczema, scalp mycosis.
- Participant presenting signs or symptoms of hyperandrogenism, such as: hirsutism, moderate to severe acne.
- Participant with previous diagnosis of hormonal disorders, such as: polycystic ovary syndrome, ovarian or adrenal tumors.
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 |
|---|---|---|
| N1087N1087 is an oral solution administered in drops. Treatment begins with an 8-week titration period: 0.5 mg/day for 2 weeks, then 1 mg/day, 1.5 mg/day, and up to 2 mg/day every 2 weeks. After titration, participants continue for 16 weeks at the maximum tolerated dose (up to 2 mg/day). Administered orally once daily for a total of 24 weeks. | Drug | N1087 |
| PlaceboPlacebo administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding. | Drug | Placebo |
Primary outcome
Change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target scalp area at Week 24
Time frame: 24 weeks
Non-vellus hair density (≥0.03 mm diameter) will be measured in the target scalp area using standardized digital phototrichogram. The primary endpoint is the absolute change from baseline to Week 24.
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 4 Nov 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.
Taís Mendonça dos Santos contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N1087 in people with Female Pattern Hair Loss and Female Pattern Hair Loss, Androgenic Alopecia, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 6 inclusion and 29 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Natalia Silva Di Gianni (+55 11 4144-9500, natalia.gianni@eurofarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in non-vellus hair density (≥0.03 mm diameter) in the target scalp area at Week 24 (time frame: 24 weeks). 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 4 Nov 2026.