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NOT YET RECRUITING
NCT07303322
PHASE3

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

Sponsor: Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2027-01

Completion Date

2028-08

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

N1087

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.

DRUG

Placebo

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