Female androgenetic alopecia: which treatments have evidence behind them and which is approved in Spain

In Spain, the only treatment approved specifically for female androgenetic alopecia is topical minoxidil 2%. It also has the strongest evidence: according to a Cochrane review, it almost doubles the chance of noticing visible regrowth compared with placebo. The other options people talk about (oral minoxidil, spironolactone) have more limited data, and the Spanish Agency of Medicines and Medical Devices (AEMPS) does not list them for this indication. Which option is right depends on the diagnosis and on each woman.

What female androgenetic alopecia is and why it happens

Female androgenetic alopecia (FAGA), also called female pattern hair loss, is the most common type of hair loss in women. The hair does not fall out all at once. In some follicles the growth phase (anagen phase) gets shorter, and each cycle produces a hair that is finer and shorter. Over time, a thick terminal hair ends up as an almost invisible vellus hair. This is called follicular miniaturisation.

That is why women don't usually get a receding hairline as men do. Instead, density thins out across the top of the head and the parting gets steadily wider. Severity is measured with visual scales. The Ludwig scale, with 3 grades, is the most widely used, and the Sinclair scale has 5 grades.

How many women have it

It is more common than most people think, and it becomes more common with age. In white women in the United Kingdom and the United States, using the Ludwig criterion of above grade I, overall prevalence is around 11.8%. It goes from 3-6% before the age of 30 to 29-42% from 70 onwards. In a cross-sectional study of 178 postmenopausal women, 52.2% had FAGA. Most of them were Ludwig grade I (73.2%), with 22.6% at grade II and 4.3% at grade III. That figure applies only to that group, in a small sample, and not to the general population.

What is approved in Spain

According to the summaries of product characteristics in CIMA, the AEMPS medicines database, minoxidil 2% cutaneous solution (20 mg/ml, for example Alopexy 20 mg/ml) is indicated in Spain for moderate androgenetic alopecia in adults, both men and women. The summary of product characteristics gives a dose of 1 ml every 12 hours.

The 5% strength (50 mg/ml, for example Alopexy 50 mg/ml) is a different matter. Its summary of product characteristics indicates it only for men and advises against its use in women for two reasons: limited efficacy, and hypertrichosis, meaning hair growth in places where it isn't applied, such as the face, in 37% of cases. It shows clearly that a higher strength is not automatically the better choice.

What the evidence says about topical minoxidil

The 2016 Cochrane review of treatments for female pattern hair loss is the most thorough analysis available. With topical minoxidil, mostly at 2%, 157 out of 593 women noticed a moderate to marked increase in hair growth, compared with 77 out of 555 on placebo. That is a relative risk of 1.93, based on moderate-quality evidence. In the 8 studies that measured hair count (1,242 participants), minoxidil added an average of 13.18 more hairs per square centimetre than placebo.

Looked at carefully, the data tell us two things. It works better than doing nothing, but not for every woman, and the results are not dramatic. The realistic goal is to slow miniaturisation and get back some density, not to have the hair you had at twenty. The changes also take more than a few weeks to show. In our timeline of how long a hair loss treatment takes to show results, we explain what to expect month by month.

The main European guideline for treating androgenetic alopecia in women and men is the European Dermatology Forum S3 guideline (Kanti and colleagues, 2018), published in the Journal of the European Academy of Dermatology and Venereology.

Oral minoxidil and spironolactone: what is known and what isn't

Low-dose oral minoxidil and spironolactone are coming up more and more in dermatology clinics. The first thing to know is that CIMA has no summary of product characteristics approving either of them for hair loss in women in Spain, and the same goes for finasteride. When they are used, it is off-label, and the prescribing doctor takes responsibility.

On efficacy, the most often cited data come from a 24-week randomised trial in 52 women aged 18 to 65. With oral minoxidil 1 mg daily, total hair density increased by 12%, compared with 7.2% with topical minoxidil 5%. The difference was not statistically significant (p=0.09). The authors concluded that the oral form was effective and safe at 24 weeks, but not superior to the topical one. We go into this in more detail in oral versus topical minoxidil: what the head-to-head trials show.

For spironolactone combined with oral minoxidil, the data we have cover safety, not efficacy. A retrospective cohort of 432 women taking both drugs recorded side effects in 37.7%. The main ones were hypertrichosis (12.3%) and dizziness, unsteadiness or a drop in blood pressure on standing up (12.0%). Starting both drugs at the same time was linked to up to 64.8% less hypertrichosis, and taking other antihypertensives increased the risk of orthostatic effects. There is more detail in our map of the real-world side effects of low-dose oral minoxidil.

Clinical assessment: what a doctor checks before treating

Not all hair loss in women is androgenetic alopecia, and the treatment is completely different depending on the cause. That is why the assessment starts with the diagnosis, not the drug. These are the points that usually matter most:

• Confirming the pattern: gradual loss of density on the top of the head with hairs of uneven thickness. This is different from sudden, diffuse shedding such as telogen effluvium, which usually resolves, and from patches or scarring, which point to other diagnoses.
• Grading severity on a scale such as the Ludwig or Sinclair scale, so there is a starting point to compare progress against.
• Reviewing regular medication, especially blood pressure drugs, because they affect the risk of orthostatic effects if oral treatment is being considered.
• Explaining which option is approved in Spain and which would be used off-label, with their efficacy data and known side effects, such as hypertrichosis.
• Setting realistic expectations and a follow-up plan that gives enough time to judge the response.

Key points

Female androgenetic alopecia is common, it gets worse over time, and there is evidence-based treatment for it. Topical minoxidil 2% is the approved option and has Cochrane backing. The oral alternatives have promising but more limited data. In Spain today, if you notice your hair losing density, medical treatment for hair loss starts with an assessment: a registered doctor confirms the diagnosis, prescribes when appropriate and keeps monitoring how you respond. That is what we do at AiON. You can find out in a few minutes whether treatment is right for you.