Phase III Study of Oral Minoxidil 1 mg for Treating Female Androgenetic Alopecia

What this Trial Is About

Researchers are evaluating oral minoxidil 1 mg for women with androgenetic alopecia, a type of hormone-related hair loss. This phase III clinical trial aims to compare the effectiveness of oral minoxidil 1 mg to a 2% topical minoxidil solution and placebo, while also monitoring safety. Approximately 520 adult female patients with this condition will participate across multiple centers in Europe. Participants will be randomly assigned to one of three groups oral minoxidil 1 mg once daily plus a topical vehicle solution twice daily an oral placebo once daily plus topical 2% minoxidil solution twice daily or oral placebo once daily plus a topical vehicle solution twice daily. The treatment period lasts six months, with doses taken mainly at home, and includes a screening period and a four-week follow-up. During the 36-week study, patients will visit the clinic five times for examinations and receive two safety phone calls. Assessments include hair photos to measure density, scalp hair growth evaluations, vital signs, blood and urine tests, ECGs, and checks for excessive hair growth. Participants will track daily side effects, medication changes, and pregnancy tests if applicable. The main outcome is the change in hair count in the target scalp area from baseline to week 24.

Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia