A Phase 2, Randomised, Open-Label, Dose-Ranging Study of Minoxidil Sublingual (SL) Tablets in the Treatment of Male Androgenetic Alopecia (AGA) in Adults

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000182392

Enrollment

120

Registered

2026-02-11

Start date

2026-02-12

Completion date

2026-05-28

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a Phase 2, Randomised, Open-Label, Dose-Ranging Study of Minoxidil Sublingual (SL) Tablets in the Treatment of Male Androgenetic Alopecia (AGA) in Adults The study will evaluate the safety and efficacy of three doses of minoxidil (5 mg, 7.5 mg, 10 mg) SL tablets in participants who have completed all study visits in the preceding SAM-002 study (placebo and active). Participants will be randomised 1:1:1 to two 2.5 mg minoxidil SL tablets, three 2.5 mg minoxidil SL tablets, and four 2.5 minoxidil SL tablets daily. The study duration is up to 48 weeks. Approximately 120 participants are expected to take part in this open label extension study. The efficacy objective is to evaluate the effect of varying doses of SL minoxidil tablets over 48 weeks on Target Area Hair Count (TAHC) in men with AGA. The study evaluates efficacy from Baseline to Week 48 using a Primary Endpoint of mean change in vertex scalp TAHC via macro-photography, and Secondary Endpoints including global and macro photographic hair assessments, PROs (PGA and CMPHL-PRO), and investigator-blinded evaluations. Safety will be evaluated over 48 weeks by assessing the tolerability of minoxidil SL tablets across dose levels through comparison of the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious adverse events (SAEs), and clinically significant changes in vital signs and electrocardiograms (ECGs) from Baseline to Week 48.

Interventions

This is an open label, dose ranging study. The study will evaluate the safety and efficacy of three doses of 2.5 mg minoxidil SL tablets. Participants will be randomised 1:1:1 to two 2.5 mg minoxidil SL tablets, three 2.5 mg minoxidil SL tablets, and four 2.5 minoxidil SL tablets daily for 48 weeks. Participants will be contacted by telephone to inquire about general wellbeing and treatment compliance on Day 14 (Visit 2), Day 42 (Visit 3), Day 126 (Visit 5), Day 210 (Visit 7), and Day 294 (Visit 9). Participants are required to be at least 85% compliant with the treatment regimen. Participants who have missed sequential doses on more than one occasion between in-clinic visits will be re-educated on how to take the medication. If the participant continues to be non-compliant, they may be withdrawn as per the Principal Investigator's discretion. Treatment adherence will be assessed using multiple methods, including participant self-report during scheduled telephone contacts and in-clinic visits, review of participant diaries for medication compliance and recording of any treatment-emergent adverse events (TEAEs), and tablet accountability. Remaining unused study medication, including partially used and empty blister packs, will be returned to the Investigator at designated visits, and tablet compliance will be calculated based on the number of tablets returned by the participant. Participants are required to maintain at least 85% compliance with the assigned dosing regimen. Participants who miss sequential doses on more than one occasion will be re-educated on correct medication administration. Participants who miss a total of 50 doses over the duration of the study will be withdrawn from the study due to non-compliance with the protocol, at the discretion of the Principal Investigator.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Participants must have successfully completed the End of Study (EOS) visit for the SAM-002 study. • Participants must be willing and able to attend all study visits and comply with study requirements and study procedures including scalp re-tattooing (if required) and hair trimming. • Participants must be willing to maintain the same hair style, hair colour, and hair length • Participants must be able to comprehend and willing to sign and date a written Patient Informed Consent Form (PICF).

Exclusion criteria

• Participants who did not complete the EOS visit for the SAM-002 study. • Participants who were less than 85% compliant in the SAM-002 study. • Participants with any new medical condition or change in health status since completion of the SAM-002 study that would make participation unsafe or interfere with study assessments, in the opinion of the Investigator • Participants with planned surgery prior to completion of all study procedures. • Participants that are unwilling to comply with all study procedures and assessments.

Outcome results