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Study on the Effectiveness and Safety of Oral Minoxidil for Women with Androgenetic Alopecia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Minoxidil on women experiencing a type of hair loss known as female androgenetic alopecia, which is often related to hormonal imbalances. The study will compare the effectiveness and safety of taking Minoxidil in a 1 mg tablet form, taken orally once a day, against a placebo, which is a substance with no active medication. Additionally, the study will involve a topical solution, which is applied directly to the skin, to further assess the treatment's impact on hair growth.

The purpose of the study is to determine if the oral Minoxidil treatment is as effective as the control treatment, which includes a placebo tablet and a topical solution containing 2% Minoxidil. Participants will be randomly assigned to different groups to receive either the active treatment or the placebo. The study will last for about six months, during which participants will have regular check-ups to monitor changes in hair growth and overall health. The main focus will be on the change in the number of non-vellus hairs, which are thicker and more visible, in a specific target area of the scalp.

Throughout the study, participants will be asked to maintain their usual hair care routines and will be monitored for any side effects or changes in their health. The study aims to provide valuable information on the potential benefits of Minoxidil for women with hormone-related hair loss, helping to improve treatment options for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the clinical trial, you will start by taking an oral tablet once a day. This tablet contains minoxidil at a dose of 1 mg. You will also apply a topical solution twice a day. This solution is a vehicle, meaning it does not contain active medication.

    The purpose of this stage is to evaluate the effectiveness and safety of the treatment over a period of 24 weeks, which is approximately 6 months.

  2. Step 2

    Midpoint evaluation

    At week 12, which is about 3 months into the trial, you will undergo an evaluation. This will include checking the number of hairs in a specific area of your scalp, as well as the width and density of these hairs.

    Your overall health will also be assessed through laboratory tests, including blood and urine tests, and a physical examination. Vital signs such as blood pressure, pulse rate, and body temperature will be measured.

  3. Step 3

    End of treatment evaluation

    At week 24, the end of the treatment phase, another evaluation will take place. This will involve similar assessments as at week 12, including hair counts, hair width, and hair density.

    Your health will be monitored again with laboratory tests, vital signs, and a physical examination. An electrocardiogram (ECG) will also be performed to check your heart's activity.

  4. Step 4

    Final follow-up

    At week 28, a final follow-up visit will occur. This visit is to ensure your well-being after the treatment has concluded.

    During this visit, any side effects or changes in your health will be reviewed. This includes a final check of your vital signs and a physical examination.

Who can join the trial?

9 criteria

  • Female patients aged 18 years or older, in general good health, meaning no history of heart problems or other significant diseases.
  • Diagnosed with Female Androgenetic Alopecia (FAGA), which is a noticeable decrease in hair density in the central part of the scalp.
  • Hair color must provide enough contrast with the scalp, confirmed by a special technology at the first screening visit.
  • Must sign a consent form indicating understanding of the clinical trial details.
  • Negative pregnancy test results at the first screening visit and at the baseline visit for women who can become pregnant.
  • Women who can become pregnant must be permanently sterile or agree to use a highly effective birth control method during the trial and for at least two weeks after the last treatment. Certain birth control pills with antiandrogen properties are allowed if used consistently for at least six months before the baseline visit and planned to continue throughout the trial.
  • Must be willing to keep the same hairstyle, hair color, and hair care routine throughout the trial. Hair length should be long enough to not affect hair density measurements, and any changes should be discussed with trial staff.
  • Must be willing to maintain the same habits and intervals for removing facial or body hair before each visit during the trial.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, undergo lab tests, and participate in other trial procedures, including daily diary entries using a personal electronic device with internet access.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Oral Minoxidil

    is a medication used in this trial to help with hair growth in women experiencing hair loss due to androgenetic alopecia. It is taken by mouth in the form of a tablet. The goal of using oral minoxidil in this study is to see if it can effectively increase the number of hairs in a specific area of the scalp over a period of six months.

  • Topical Minoxidil Solution

    is a liquid applied directly to the scalp. In this trial, it is used as a comparison to see how well it works against the oral form of minoxidil. The solution is applied twice a day to help stimulate hair growth in women with androgenetic alopecia. The study aims to compare the effectiveness of the topical solution with the oral tablet form of minoxidil.

What is already known about the treatment

Oral Minoxidil – Oral Minoxidil is administered in tablet form, taken once daily, and is currently being studied in a Phase III clinical trial for its effectiveness and safety in treating female androgenetic alopecia, a common form of hair loss in women. This medication is being compared to a placebo and a topical minoxidil solution to determine its efficacy in increasing hair count. Minoxidil works by widening blood vessels, which improves blood flow to hair follicles, potentially stimulating hair growth. It is classified as a vasodilator, a type of medication that helps expand blood vessels.

Investigated diseases

Female androgenetic alopecia – Female androgenetic alopecia is a common form of hair loss in women, characterized by a gradual thinning of hair on the scalp. It typically begins with a widening of the part line and can progress to diffuse thinning across the top of the head. The condition is influenced by genetic and hormonal factors, particularly the presence of androgens. Over time, hair follicles shrink, leading to shorter and finer hair strands. The progression of hair thinning can vary among individuals, with some experiencing more rapid hair loss than others. Despite the thinning, complete baldness is rare in female androgenetic alopecia.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503383-17-01Protocol codeP22112aEstimated enrolment459 patientsSponsorIndustrial Farmaceutica Cantabria S.A.

sourced from the EU Clinical Trials Register and site verification

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