Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

NCT06924632 | Recruiting Phase 3

• 1 other identifier: SAM-002
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Hair Loss; Male Pattern Balding

Outcome Measures

Primary Outcomes (1)

• Mean Change in Non-vellus Target Area Hair Counts (TAHC)

  Mean change in the vertex scalp non-vellus TAHC from baseline to week 24.

  24 Weeks

Study Arms (2)

2.5 mg Sublingual Minoxidil BID

EXPERIMENTAL

2.5 mg sublingual minoxidil to be taken twice a day, once in the AM and once in the PM.

Drug: Minoxidil

Placebo BID

PLACEBO COMPARATOR

placebo to be taken sublingually twice a day, once in the AM and once in the PM.

Drug: Placebo

Interventions

Minoxidil DRUG

2.5 mg Sublingual Minoxidil Tablet

2.5 mg Sublingual Minoxidil BID

Placebo DRUG

Placebo

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Norwood-Hamilton Type IIIa, IVa, and Va grades (i.e. participants must have vertex balding).
• Use of topical minoxidil, oral minoxidil, dutasteride, finasteride, drugs with anti-androgenetic or androgenetic properties, or medications that cause hypertrichosis or hypotrichosis within the 6 months prior to enrolment.
• Laser treatment of the scalp within 3 months prior to enrolment.
• History of scalp micropigmentation or hair restoration surgery.
• Use of wigs, hair extensions, hair pieces, or hair weaves at time of enrolment.
• Use of anti-hypertensive medication.
• Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device, or participation in such a trial within 3 months or 5 half-lives of the investigational product, whichever is longer, prior to receiving the first dose.
• History of hypersensitivity or allergies to minoxidil or any of the excipients contained in the study medication.
• Known allergy or sensitivity to tattoo ink.
• Dermatological disorder (e.g. eczema, psoriasis) or infection affecting the target area (vertex or centroparietal area).
• Scalp characteristics, including scarring, that may interfere with examinations.
• Medical condition which adversely affects hair loss.
• Specific underlying conditions (e.g. cardiovascular disease, congestive cardiac failure, cardiac arrhythmia, systemic lupus erythematosus, history of phaeochromocytoma, pulmonary hypertension secondary to mitral stenosis, minoxidil hypersensitivity), clinically significant findings from medical history, clinical laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the participant at risk.
• Moderate to severe renal or hepatic impairment.
• Hypotension (blood pressure less than 90/60 mmHg) or a history of significant symptomatic postural hypotension.

Sponsors & Collaborators

• Samson Clinical Operations Pty Ltd: lead

Study Sites (3)

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

NOT YET RECRUITING

DIRECT

East Melbourne, Victoria, 3002, Australia

RECRUITING

DIRECT

Pascoe Vale, Victoria, 3044, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)