International Phase III, Multi-center, Randomized, Double-blind, Placebo and Active-controlled and Parallel group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female patients with Androgenetic Alopecia.

Female androgenetic alopecia

The main (primary) efficacy endpoint is the change from Baseline in TAHC at Week 24 (6 months)

Secondary efficacy endpoints: Change from Baseline in TAHC at Week 12, Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Width (TAHW) at Weeks 12 and 24, Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Density (TAHD) at Weeks 12 and 24, Secondary efficacy endpoints: Investigator's Global Assessment (IGA) at Weeks 12 and 24, Secondary efficacy endpoints: Women’s Androgenetic Alopecia Quality of Life (WAA-QoL) at Weeks 12 and 24, Secondary safety endpoints: Overall number of treatment emergent adverse events (TEAEs) (including serious TEAEs) up to the end of the clinical trial (Visit 7/Week 28), Secondary safety endpoints: Change from Baseline in safety laboratory parameters (hematology, clinical chemistry, and urinalysis) to Visit 4/Week 12 and Visit 6/Week 24, Secondary safety endpoints: Change from Baseline in vital signs (blood pressure, pulse rate, body temperature) to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28, Secondary safety endpoints: Evaluation of 12-lead electrocardiogram (ECG) to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28, Secondary safety endpoints: Evaluation of physical examination to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28, Secondary safety endpoints: Evaluation of hypertrichosis to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28

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