Androgenetic AlopeciaPhase 3NCT06924632
Efficacy & Safety of Minoxidil SL Tablets in Men With AGA
A Phase 3 study testing Minoxidil in people with Androgenetic Alopecia and Male Pattern Baldness, run by Samson Clinical Operations Pty Ltd at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Androgenetic Alopecia, Male Pattern Baldness
- What is being tested?
- Minoxidil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 3 sitesAustralia
- Study dates
- 14 Jul 2025to 15 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Untreated or uncontrolled hypertension (blood pressure greater than 150/90 mmHg, not stable on current medication for the past 3 months).
- History or evidence of hair loss other than androgenetic alopecia.
- Unwilling to comply with all study procedures and assessments.
- Scalp hair length less than ~2.5 cm
- History of alcohol and/or substance abuse, or drug-abuse disorders.
- Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures.
- Site employees or immediate family members of study site employees.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
DIRECT
East Melbourne, Victoria, 3002
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217
DIRECT
Pascoe Vale, Victoria, 3044
About this study
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
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
- Being tested
- Minoxidil, Placebo
- Keywords
- Hair Loss, Male Pattern Balding
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
2.5 mg Sublingual Minoxidil Tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Minoxidil |
| Placebo BID | Placebo comparator | placebo to be taken sublingually twice a day, once in the AM and once in the PM. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Non-vellus Target Area Hair Counts (TAHC)
Mean change in the vertex scalp non-vellus TAHC from baseline to week 24.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start14 Jul 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samson Clinical Operations Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924632
- Sponsor's protocol ID
- SAM-002
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06924632
- Acronym / sponsor ID
- SAM-002
- Conditions
- Androgenetic Alopecia, Male Pattern Baldness
- Keywords
- Hair Loss, Male Pattern Balding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Samson Clinical Operations Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg Sublingual Minoxidil BID | Experimental | Drug: Minoxidil2.5 mg sublingual minoxidil to be taken twice a day, once in the AM and once in the PM. |
| Placebo BID | Placebo comparator | Drug: Placeboplacebo to be taken sublingually twice a day, once in the AM and once in the PM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minoxidil2.5 mg Sublingual Minoxidil Tablet | Drug | 2.5 mg Sublingual Minoxidil BID |
| PlaceboPlacebo | Drug | Placebo BID |
Primary outcome
Mean Change in Non-vellus Target Area Hair Counts (TAHC)
Time frame: 24 Weeks
Mean change in the vertex scalp non-vellus TAHC from baseline to week 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minoxidil in people with Androgenetic Alopecia and Male Pattern Baldness, run by Samson Clinical Operations Pty Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Non-vellus Target Area Hair Counts (TAHC) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.