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Not yet recruitingNCT07516561MONAUpdated Sep 8, 2026

Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

A Phase 3 interventional study of APSMNF 1 and APSMNF 2 in Alopecia, Androgenetic, sponsored by Apsen Farmaceutica S.A.. Not yet recruiting at 1 site in Brazil. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Apsen Farmaceutica S.A. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.

02

Conditions studied

  • Alopecia, Androgenetic

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03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 336 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Apsen Farmaceutica S.A. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ;
  • Participants who use an acceptable 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
336 participants (estimated)

Study arms

  • Experimental
    APSMNF 1

    active

    Drug: APSMNF 1

  • Experimental
    APSMNF 2

    active

    Drug: APSMNF 2

  • Active comparator
    Eniagor®

    active

    Drug: Eniagor®

Interventions

  • DrugAPSMNF 1

    Administer twice a day during 24 weeks.

  • DrugAPSMNF 2

    Administer twice a day during 24 weeks.

  • DrugEniagor®

    Administer twice a day during 24 weeks.

06

What researchers measure

Primary outcomes

  1. Variation in hair density assessed by phototrichogram.

    Time frame: Change from baseline after 24 weeks of treatment.

Secondary outcomes

  1. Adverse events incidence and classification

    Time frame: Through study completion, up to 24 weeks

07

Study locations

1 site
  • Clinica Geral Investiga Ltda
    Campinas, São Paulo, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07516561
Lead sponsor
Apsen Farmaceutica S.A.
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Oct 7, 2026 (estimated)
Primary completion
Aug 2, 2029 (estimated)
Completion
Aug 2, 2029 (estimated)
Last update
Sep 8, 2026

Study contacts

Bianca Zanetti
Contact
bianca.zanetti@apsen.com.br
+55115641-2305

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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