Is Testosterone Licensed for Women in the UK?

No testosterone product is licensed for women in the UK. That sounds like a warning, and it is worth understanding properly, because it is not the same as testosterone being unapproved, untested or unavailable. It means prescribers use products licensed for men, at much lower doses worked out for women. That is called off-label prescribing, and it is a normal, regulated part of medicine.

What off-label actually means

A licence describes the specific uses a manufacturer has applied for and had approved. When a doctor or nurse prescriber uses a medicine outside those exact terms, for a different group of people or a different purpose, that use is off-label. The prescriber takes personal responsibility for the decision, has to be able to justify it, and should explain it to you and record your consent.

It is common. A great deal of prescribing in children, in pregnancy and in menopause care is off-label, simply because the licensing studies were never done in those groups. In this case the reason is commercial rather than clinical: the doses women need are small, the market is smaller than the male one, and no manufacturer has taken a female product through UK licensing.

So what do prescribers actually use?

• •Gels and creams licensed for men, used in much smaller measured amounts.
• •AndroFeme, a cream made for women and licensed in Australia, which can be imported and prescribed here.
• •Nothing that can be bought over the counter. All of it is prescription-only, whichever product is chosen.

Who is allowed to prescribe it

Any qualified prescriber can, including GPs and independent nurse prescribers, provided they are competent to do so and can justify the decision. In practice confidence varies a lot. Some GPs prescribe testosterone for menopausal women routinely; others have never done it and would rather refer. Neither position is wrong, and the second is not a judgement about you.

Does off-label mean it is unproven?

No, and this is the part worth separating out. The British Menopause Society supports testosterone for menopausal women whose low sexual desire has not improved on HRT alone. There is evidence behind that specific use. What is missing is a company having paid for a UK licence, not the evidence itself. Where the evidence genuinely is thin is everything beyond desire, which we cover in what testosterone does for women, and what it does not.

What this means for you in practice

• •You should be told it is off-label before you start, and asked to consent to that specifically.
• •The reason should be recorded: what has already been tried, and why testosterone is being considered now.
• •Monitoring is part of the deal rather than an optional extra, because the dose has to stay in the range intended for women.
• •If a service does not mention the words off-label at all, that is a reasonable thing to ask about.

How Solene fits

Solene is a nurse-led menopause service. Where testosterone is clinically appropriate, a nurse prescriber explains the off-label position, records your consent to it separately, and arranges the monitoring that goes with it. You can see what is included on our treatment plans page.