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Androgenetic AlopeciaPhase 3NCT05888922

Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

A Phase 3 study testing Minoxidil Tablets and Minoxidil Topical in people with Androgenetic Alopecia and Female Pattern Baldness, run by Industrial Farmacéutica Cantabria, S.A. at 27 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase III clinical trial is evaluating whether oral minoxidil 1 mg is an effective and safe treatment for women with androgenetic alopecia (female pattern hair loss). Approximately 520 women is planned to take part in the study. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Minoxidil Tablets and Minoxidil Topical
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
520 participants
Where
27 sitesin 4 countries
Study dates
17 Oct 2024to 16 Nov 2026
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18 years or older, with general good health (i.e., with no history of cardiovascular disorders, or any other clinically significant disease).
  • Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale 2-4) in the centroparietal area of the scalp.
  • Hair color of patient provides sufficient contrast with the scalp and as confirmed by TrichoLab Virtual Tattoo® technology at Screening/Visit 1.
  • A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial.
  • Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test at Visit 2/Baseline for women of child-bearing potential (WOCBP).
  • WOCBP must either be permanently sterile1 or agree to use a highly effective birth control method (failure rate ˂1% per year when used consistently and correctly) throughout the clinical trial and for at least 2 weeks after last administration of IPs.
Show all 10Show fewer
  • Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest) are allowed if treatment is stable since the last 6 months prior to Visit 2/Baseline and if used as contraceptive and planned to be continued throughout the clinical trial duration.
  • Patients willing to maintain the same hairstyle (color and hair regimen) throughout the clinical trial. Hair length must remain of sufficient length to not affect determination of hair density and patient should discuss with clinical trial personnel before changing from Visit 2/Baseline.
  • Patient is willing to maintain the same depilatory habits and intervals regarding facial or body hair before each visit throughout duration of the clinical trial.
  • Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical trial procedures, including daily e diary recordings by the patient using an own electronic device (e.g., tablet, smartphone, personal computer) and an internet connection during the clinical trial.

Who cannot join

  • Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products.
  • Pregnancy or pregnancy desire during the clinical trial.
  • Breastfeeding/Nursing women.
  • Any diagnosed treated or untreated hypertension (or blood pressure values >150 mmHg systolic / >95 mmHg diastolic) as determined at Visit 1/Screening, and/or history/signs of known cardiovascular diseases (including but not limited to cardiac ischemia, congestive heart failure, cardiac arrhythmia), and patients with pathologies or punctual situations that might either be caused by or increase the risk of cardiac disorders.
  • Patients with any dermatological disorders of the scalp in the target region at Visit 1/Screening with the possibility of interfering with the application of the IPs or examination method, such as
  • Active moderate or severe seborrheic dermatitis under chronic treatment, abrasion, actinic keratosis, or inflammatory disorders, or
Show all 35Show fewer
  • any local infection of the skin/subcutaneous tissues of the head within the previous 3 months, or
  • any documented history of active atopic dermatitis or psoriasis in the scalp within the previous 6 months.
  • any other types of alopecia (e.g., alopecia areata or scarring alopecia) at any time point or diffuse telogen effluvium, trichotillomania, or other pathological hair loss conditions/diseases other than AGA in the last 3 months at the discretion of the investigator).
  • Patients who had hair transplant surgery at any time.
  • Patients who had hair weaving, or any other hair extension methods within the last 6 months prior to Visit 2/Baseline.
  • Clinically significant abnormal laboratory values or ECG findings (if applicable) at Visit 1/Screening indicative of physical illness, according to investigator assessment.
  • Both creatinine and eGFR above upper limit of normal at Visit 1/Screening.
  • Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases that in the opinion of the investigator may interfere with the aim of the clinical trial.
  • Patient has used any of the following topical preparations or procedures on the scalp:
  • Topical scalp treatments for hair growth, including minoxidil within the last 6 months prior to Visit 2/Baseline; or hormone therapy, antiandrogens, or other agents that are known to affect hair growth within 12 weeks prior to Visit 2/Baseline.
  • Topical scalp treatments that might have had ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, and tacrolimus within the last 4 weeks prior to Visit 2/Baseline.
  • Topical scalp over the counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene®, Nioxin®, Foltene®, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within the last 4 weeks prior to Visit 2/Baseline.
  • Light or laser treatment or microneedling of scalp within the last 6 months prior to Visit 2/Baseline.
  • Platelet rich plasma (PRP) procedure on the scalp within the last 6 months prior to Visit 2/Baseline.
  • Patient has used the following systemic medications or procedures:
  • Zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines, or other vasodilators or antihypertensive agents such as guanethidine and derivatives within the last 12 months prior to Visit 2/Baseline.
  • Any 5 alpha reductase medications (i.e., dutasteride, finasteride [Propecia®, etc.] or similar product[s]) within the last 12 months prior to Visit 2/Baseline.
  • Retinoid therapy within the last 6 months prior to Visit 2/Baseline.
  • Beta blockers, anabolic steroids, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable (defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline.
  • Drugs with antiandrogenic properties, such as flutamide, cimetidine, or ketoconazole within the last 6 months prior to Visit 2/Baseline; bicalutamide within 2 months and spironolactone within 1 month prior to Visit 2/Baseline. Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest) are allowed if treatment is stable since the last 6 months prior to Visit 2/Baseline and if used as contraceptive.
  • Minoxidil within the last 6 months prior to Visit 2/Baseline.
  • Prostaglandins and derivates within the last 3 months prior to Visit 2/Baseline. Topical and ocular prostaglandins and its derivates are allowed.
  • Biotin (>5 mg) within the last 4 weeks prior to Visit 2/Baseline.
  • Previous radiation of the scalp and treatment with chemotherapy/systemic cytotoxic agents at any timepoint.
  • Participation in the evaluation of any investigational drugs within 30 days or 5 half lives (whichever is longer) prior to Visit 2/Baseline, calculated from the first day of the month following the last visit of the previous clinical trial.
  • History of drug and alcohol dependency.
  • In the opinion of the investigator the patient should not participate in the clinical trial, e.g., due to probable non compliance or inability to understand the clinical trial and give adequately informed consent.
  • Close affiliation with the investigator (e.g., a close relative) or persons working at the clinical trial centers or patient is an employee of sponsor.
  • Patient is institutionalized because of legal or regulatory order.

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

Germany20 sites

  • Fachklinik Bad Bentheim Klinisches Studienzentrum

    Bad Bentheim

  • CRC - Charité Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Science

    Berlin

  • emovis by Futuremeds GmbH

    Berlin

  • Klinische Forschung Berlin Mitte GmbH

    Berlin

  • Hautzentrum im Jahrhunderthaus

    Bochum

  • Rosenpark Reasearch GmbH

    Darmstadt

  • Klinische Forschung Dresden GmbH

    Dresden

  • Privatpraxis Dr. Hilton & Partner

    Düsseldorf

  • Klinik für Dermatologie, Venerologie und Allergologie - Universitätsmedizin Frankfurt

    Frankfurt

  • Dermaticum - Privatpraxis für Dermatologie

    Freiburg im Breisgau

  • Eurofins bioskin - Research Center Dermatology

    Hamburg

  • Klinische Forschung Hamburg GmbH

    Hamburg

  • Klinische Forschung Hannover Mitte GmbH

    Hanover

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe

  • Siteworks - Zentrum für klinische Studien Karslruhe

    Karlsruhe

  • Siteworks - Prüfzentrum Lohne

    Löhne

  • Haut-und Lasercentrum - Dr. Tanja Fischer und Kollegen

    Potsdam

  • SGS proderm GmbH

    Schenefeld

  • Klinische Forschung Schwerin Gmb

    Schwerin

  • TRIDERM Study Site Dermatological practice Dr. Leitz and colleagues

    Stuttgart

Other trials in Germany

Portugal3 sites

  • Hospital CUF Descobertas - Ensaios Clínicos

    Lisbon

  • Personal Derma - Clínica Dermatológica & Estética

    Lisbon

  • Instituto Dermatológico da Madeira - Dermatologia e Laserterapia

    Madeirã

Other trials in Portugal

Spain3 sites

  • Hospital Clinic de Barcelona

    Barcelona

  • Clínica Grupo Pedro Jaén

    Madrid

  • Institut Medico Ricart (IMR)

    Valencia

Other trials in Spain

Italy1 site

  • Università Sapienza di Roma Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari U.O.C. di Dermatologia Centro per lo studio sulla fisiopatologia degli Annessi Cutanei Sapienza Università di Roma

    Roma

Other trials in Italy

About this study

Official title: International Phase III, Multi Center, Randomized, Double Blind, Placebo and Active Controlled and Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia

This phase III clinical trial is evaluating whether oral minoxidil 1 mg is an effective and safe treatment for women with androgenetic alopecia (female pattern hair loss).

Approximately 520 women is planned to take part in the study. Participants will be randomly assigned to receive either oral minoxidil, topical minoxidil 2% solution, or placebo. Neither the participants nor the study staff will know which treatment has been assigned.

Read more

The study will last up to 36 weeks, including a treatment period of 24 weeks and a follow-up period. Participants will attend regular study visits to assess hair growth and monitor safety.

Site investigators will evaluate changes in hair growth and hair density using scalp imaging, investigator assessments, and participant questionnaires. Safety will be monitored through physical examinations, vital signs, laboratory tests, electrocardiograms, and the recording of side effects throughout the study.

Read the detailed description

This Phase III, multicenter, randomized, double-blind, placebo- and active-controlled study will evaluate the efficacy and safety of oral minoxidil 1 mg in approximately 520 adult women with female androgenetic alopecia (Sinclair grade 2-4), enrolled across study sites in Germany, Spain, Italy, and Portugal. Participants will be randomized in a 2:2:1 ratio to receive oral minoxidil plus topical vehicle, topical minoxidil 2% plus oral placebo, or double placebo.

The study includes a screening period of up to 8 weeks, a 24-week treatment period, and a 4-week follow-up period, with approximately 10 scheduled visits. Study treatment will consist of once-daily oral administration and twice-daily topical application. The first treatment administration will be supervised at the study site, followed by self-administration at home, with treatment compliance recorded in an electronic diary.

Efficacy will be evaluated using quantitative target area hair measurements, including non-vellus hair count, hair density, and hair width, assessed through digital image analysis. Additional efficacy assessments will include investigator global evaluations based on standardized scalp photography and patient-reported quality-of-life questionnaires.

Safety assessments will include physical examinations, vital signs, electrocardiograms, clinical laboratory testing, pregnancy testing where applicable, hypertrichosis evaluations, and monitoring of adverse events and concomitant medications throughout the study. Efficacy and safety outcomes will be compared across all treatment groups.

Efficacy and safety data will be analyzed according to a predefined Statistical Analysis Plan established before database lock.

Being tested
Minoxidil Tablets, Minoxidil Topical, Placebo oral tablet, Vehicle solution
Keywords
Androgenetic alopecia, Female Pattern Baldness, FAGA, Minoxidil
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minoxidil TabletsDrug

    The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

  • Minoxidil TopicalDrug

    The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

  • Placebo oral tabletDrug

    The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

  • Vehicle solutionDrug

    The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Study groups in NCT05888922
Study groupRoleWhat they receive
Active groupExperimentalOral minoxidil 1 mg (1 tablet, OD) + topical vehicle solution (1 ml, BID)
Receives: Drug: Minoxidil Tablets; Drug: Vehicle solution
Control groupActive comparatorOral placebo (1 tablet, OD) + topical 2% Minoxidil solution (1 ml, BID)
Receives: Drug: Minoxidil Topical; Drug: Placebo oral tablet
Placebo groupPlacebo comparatororal placebo (1 tablet, OD) + topical vehicle solution (1 ml, BID)
Receives: Drug: Placebo oral tablet; Drug: Vehicle solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Target Area non vellus Hair Counts (TAHC)

    This is the change in TAHC from Baseline to Week 24 (6 months). A descriptive analysis of the TAHC score at Baseline and Week 24 will be performed by treatment group (active, control and placebo). Also, a descriptive analysis of the change from Baseline to Week 24 (Week 24 - Baseline) will be performed by treatment group (active, control and placebo).

    Measured: From baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start17 Oct 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completion16 Nov 2026 (estimated)

Resources

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
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05888922
Sponsor's protocol ID
P22112a
Status last verified
Oct 2026
First submitted
25 May 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carmina E, Azziz R, Bergfeld W, Escobar-Morreale HF, Futterweit W, Huddleston H, Lobo R, Olsen E. Female Pattern Hair Loss and Androgen Excess: A Report From the Multidisciplinary Androgen Excess and PCOS Committee. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2875-2891. doi: 10.1210/jc.2018-02548.

    PubMed 30785992

  • Russo PM, Fino E, Mancini C, Mazzetti M, Starace M, Piraccini BM. HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):608-611. doi: 10.1111/jdv.15327. Epub 2018 Dec 2.

    PubMed 30394586

  • Olsen EA. Female pattern hair loss. J Am Acad Dermatol. 2001 Sep;45(3 Suppl):S70-80. doi: 10.1067/mjd.2001.117426. No abstract available.

    PubMed 11511856

  • Famenini S, Slaught C, Duan L, Goh C. Demographics of women with female pattern hair loss and the effectiveness of spironolactone therapy. J Am Acad Dermatol. 2015 Oct;73(4):705-6. doi: 10.1016/j.jaad.2015.06.063. No abstract available.

    PubMed 26369846

  • Starace M, Orlando G, Alessandrini A, Piraccini BM. Female Androgenetic Alopecia: An Update on Diagnosis and Management. Am J Clin Dermatol. 2020 Feb;21(1):69-84. doi: 10.1007/s40257-019-00479-x.

    PubMed 31677111

  • Redler S, Messenger AG, Betz RC. Genetics and other factors in the aetiology of female pattern hair loss. Exp Dermatol. 2017 Jun;26(6):510-517. doi: 10.1111/exd.13373.

    PubMed 28453904

  • Ramos PM, Brianezi G, Martins AC, da Silva MG, Marques ME, Miot HA. Apoptosis in follicles of individuals with female pattern hair loss is associated with perifollicular microinflammation. Int J Cosmet Sci. 2016 Dec;38(6):651-654. doi: 10.1111/ics.12341. Epub 2016 Jun 1.

    PubMed 27163333

  • Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.

    PubMed 33639244

  • Shorter K, Farjo NP, Picksley SM, Randall VA. Human hair follicles contain two forms of ATP-sensitive potassium channels, only one of which is sensitive to minoxidil. FASEB J. 2008 Jun;22(6):1725-36. doi: 10.1096/fj.07-099424. Epub 2008 Feb 7.

    PubMed 18258787

  • Burton JL, Marshall A. Hypertrichosis due to minoxidil. Br J Dermatol. 1979 Nov;101(5):593-5.

    PubMed 518830

  • Zappacosta AR. Reversal of baldness in patient receiving minoxidil for hypertension. N Engl J Med. 1980 Dec 18;303(25):1480-1. doi: 10.1056/nejm198012183032516. No abstract available.

    PubMed 7432414

  • Jimenez-Cauhe J, Saceda-Corralo D, Rodrigues-Barata R, Moreno-Arrones OM, Ortega-Quijano D, Fernandez-Nieto D, Jaen-Olasolo P, Vano-Galvan S. Safety of low-dose oral minoxidil treatment for hair loss. A systematic review and pooled-analysis of individual patient data. Dermatol Ther. 2020 Nov;33(6):e14106. doi: 10.1111/dth.14106. Epub 2020 Sep 7.

    PubMed 32757405

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minoxidil Tablets and Minoxidil Topical in people with Androgenetic Alopecia and Female Pattern Baldness, run by Industrial Farmacéutica Cantabria, S.A. at 27 sites in 4 countries.

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 10 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, Portugal, Spain, Italy. 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?

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?

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?

Change in Target Area non vellus Hair Counts (TAHC) (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05888922, which also lists 12 linked publications.

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 2 Nov 2026.

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