RecruitingPhase 3NCT05888922

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

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


Sponsor

Industrial Farmacéutica Cantabria, S.A.

Enrollment

520 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of women with androgenetic alopecia, a type of hormone-imbalanced hair loss. The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2% topical solution (comparator product) and is more effective than placebo; and to ensure treatment with oral minoxidil is safe. Participants will be assigned randomly to receive one of the following treatment combinations: * the test product (oral minoxidil 1 mg, once/day) and the vehicle solution (vehicle means it looks like the comparator product, but it does not contain an active ingredient, 2 times/day), or * the placebo tablet (placebo means it looks like the test product, but it does not contain an active ingredient, once/day) and the comparator product (2% minoxidil solution, 2 times/day), or * the placebo tablet (once/day) and the vehicle solution (2 times/day). The clinical trial will take up to 36 weeks. During this time, patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice. At the visits, the following examinations will be performed: photos of the hair will be taken to determine hair density, assessment of changes in scalp hair growth, measurement of blood pressure, pulse, and body temperature, a physical examination, blood withdrawal to determine any abnormalities in the blood, urine sampling and analysis, performance of ECG, and evaluation of hypertrichosis (i.e., excessive hair growth over the body). Furthermore, patients will be asked daily whether they had experienced any side effects or took any new medications (or changed the dose of a known medication) or underwent any medical procedure. Also, women of childbearing potential must undergo pregnancy tests in blood and urine.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Minoxidil Tablets, a drug called Minoxidil Topical, and others for people with female pattern baldness and androgenetic alopecia. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMinoxidil Tablets

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.

DRUGMinoxidil Topical

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.

DRUGPlacebo oral tablet

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.

DRUGVehicle solution

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.


Locations(13)

Fachklinik Bad Bentheim Klinisches Studienzentrum

Bad Bentheim, Germany

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

Berlin, Germany

emovis by Futuremeds GmbH

Berlin, Germany

Rosenpark Reasearch GmbH

Darmstadt, Germany

Privatpraxis Dr. Hilton & Partner

Düsseldorf, Germany

Klinik für Dermatologie, Venerologie und Allergologie - Universitätsmedizin Frankfurt

Frankfurt, Germany

Dermaticum -Dr. med. Mario Bittar und Kollegen

Freiburg im Breisgau, Germany

Eurofins bioskin - Research Center Dermatology

Hamburg, Germany

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Germany

Siteworks - Prüfzentrum Lohne

Löhne, Germany

Zentrale Studienkoordination für innovative Dermatologie (ZiD) Klinik für Hautkrankheiten Universitätsklinikum Münster (UKM)

Münster, Germany

Haut-und Lasercentrum - Dr. Tanja Fischer und Kollegen

Potsdam, Germany

TRIDERM Study Site Dermatological practice Dr. Leitz and colleagues

Stuttgart, Germany

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NCT05888922


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