Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)

NCT07303322 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EF193A
• Study Type: interventional
• Target: 372
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Female Pattern Hair Loss; Female Pattern Hair Loss, Androgenic Alopecia

Keywords

Androgenetic Alopecia; Hair Loss; Female Pattern Hair Loss; Alopecia; Randomized Controlled Trial; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

N1087 DRUG

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.

N1087

Placebo DRUG

Placebo administered once daily for 24 weeks, following the same titration schedule as the experimental arm to maintain blinding.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luiza Terranova

CONTACT

+ 55 11 5090-8421; luiza.terranova@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-12