Phase 3, Multicentre, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Minoxidil Sublingual (SL) Tablet (2.5 mg) Twice Daily (BID) in the Treatment of Male Androgenetic Alopecia (AGA) in Adults
This is a phase 3, multicentre, randomised, double-blinded, placebo-controlled study examining the safety and efficacy of 2.5 mg sublingual (SL) minoxidil tablets taken twice daily in the treatment of androgenetic alopecia (AGA) in men. The duration of study participation is 32 weeks including screening and safety follow up. The primary efficacy objective is to determine whether treatment with 2.5 mg SL tablets twice daily increases the number of hairs in men with AGA over 24 weeks. The primary safety objective is to evaluate the safety and tolerability of 2.5 mg SL tablets administered twice daily over 24 weeks.
• Cisgender males of at least 18 years of age (inclusive) at the time of Screening.
• In good general health in the opinion of the Investigator.
• Presence of androgenetic alopecia with hair density reduction in the centroparietal area or vertex of the scalp classified as Norwood-Hamilton Type III vertex, IV, V or VI.
• Willing and able to attend all study visits and comply with treatment plan and required study procedures including scalp tattooing and hair trimming.
• Willing to maintain the same hair style, hair colour, and hair length in non-balding areas.
• Able to comprehend and willing to sign and date a written patient informed consent form (PICF).