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

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.

NCT Number	NCT07303322
Lead Sponsor	Eurofarma Laboratorios S.A.
Conditions	Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Enrollment	372 participants
Start Date	2027-01
Primary Completion	2028-07 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-01-09