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RECRUITING
NCT06924632
PHASE3

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Sponsor: Samson Clinical Operations Pty Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-07-14

Completion Date

2026-07

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

DRUG

Minoxidil

2.5 mg Sublingual Minoxidil Tablet

DRUG

Placebo

Placebo

Locations (3)

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

DIRECT

East Melbourne, Victoria, Australia

DIRECT

Pascoe Vale, Victoria, Australia