NCT06924632

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Samson Clinical Operations Pty Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Androgenetic Alopecia
• Male Pattern Baldness

Interventions

Type	Name	Description
DRUG	Minoxidil	2.5 mg Sublingual Minoxidil Tablet
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-04-11
• Last updated: 2025-07-25

Locations

3 sites across 1 country: Australia