Alopecia, AndrogeneticPhase 3MONANCT07516561
Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia
A Phase 3 study testing APSMNF 1, APSMNF 2 and Eniagor® in people with Alopecia, Androgenetic, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- APSMNF 1, APSMNF 2 and Eniagor®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Oct 2026to 2 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ;
- Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period.
Who cannot join
- History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation;
- Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
- Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening;
- Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Clinica Geral Investiga Ltda
Campinas, São Paulo
Ana Carla Mesquita, +55(19) 998187595, mesquita.anacarla@gmail.com
About this study
Official title: Phase III Randomized, Multicenter, Double-blind, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia
The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.
- Conditions
- Alopecia, Androgenetic
- Being tested
- APSMNF 1, APSMNF 2, Eniagor®
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSMNF 1Drug
Administer twice a day during 24 weeks.
APSMNF 2Drug
Administer twice a day during 24 weeks.
Eniagor®Drug
Administer twice a day during 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| APSMNF 1 | Experimental | active Receives: Drug: APSMNF 1 |
| APSMNF 2 | Experimental | active Receives: Drug: APSMNF 2 |
| Eniagor® | Active comparator | active Receives: Drug: Eniagor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in hair density assessed by phototrichogram.
Measured: Change from baseline after 24 weeks of treatment.
Secondary outcomes (1)
Adverse events incidence and classification
Measured: Through study completion, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start7 Oct 2026 (estimated)
- Primary completion2 Aug 2029 (estimated)
- Study completion2 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia, AndrogeneticStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516561
- Sponsor's protocol ID
- APS001/2025
- Acronym
- MONA
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Multicenter, Double-blind, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07516561
- Acronym / sponsor ID
- MONA / APS001/2025
- Conditions
- Alopecia, Androgenetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 2 Aug 2029 (estimated)
- Study completion
- 2 Aug 2029 (estimated)
- First posted
- 8 Apr 2026 (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.
The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APSMNF 1 | Experimental | Drug: APSMNF 1active |
| APSMNF 2 | Experimental | Drug: APSMNF 2active |
| Eniagor® | Active comparator | Drug: Eniagor®active |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ;
- Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period.
Key exclusion criteria (4 listed)
- History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation;
- Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
- Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening;
- Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;
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 |
|---|---|---|
| APSMNF 1Administer twice a day during 24 weeks. | Drug | APSMNF 1 |
| APSMNF 2Administer twice a day during 24 weeks. | Drug | APSMNF 2 |
| Eniagor®Administer twice a day during 24 weeks. | Drug | Eniagor® |
Primary outcome
Variation in hair density assessed by phototrichogram.
Time frame: Change from baseline after 24 weeks of treatment.
1 secondary outcome
Adverse events incidence and classification
Time frame: Through study completion, up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APSMNF 1, APSMNF 2 and Eniagor® in people with Alopecia, Androgenetic, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bianca Zanetti (+55115641-2305, bianca.zanetti@apsen.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in hair density assessed by phototrichogram. (time frame: Change from baseline after 24 weeks of treatment.). 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 8 Sep 2026.