Testosterone for Women: What the UK Approval Actually Means
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Testosterone for Women: What the UK Approval Actually Means

In August 2025, the MHRA approved AndroFeme — the first testosterone product designed specifically for women — in the UK. Here's what that means for women seeking treatment, who is eligible, what the evidence actually shows, and what remains uncertain.

By Vitae Team •

Originally published October 2025 · Updated May 2026 with the February 2025 Pharmaceutical Journal prescribing review, the 2025 Arch Womens Ment Health pilot study on testosterone and cognition, and NHS prescribing guidance updated September 2025

Testosterone has been prescribed to women in the UK for years — but always off-label, always using products designed for men, and always in the shadow of regulatory uncertainty. That changed in August 2025, when the MHRA granted the UK's first marketing authorisation for a testosterone product specifically designed and dosed for women.

AndroFeme 1% testosterone cream — already licensed in Australia since 2020 and subsequently in New Zealand and South Africa — is now the fourth country approval for a product that practitioners and patients have been using in the UK privately for years under special licence. The approval does not change what the treatment does. It changes the regulatory and practical landscape around accessing it.

Understanding what that means — and what it does not mean — requires understanding both the evidence for testosterone in women and the current limitations of that evidence.

TL;DR

  • In August 2025 the MHRA approved AndroFeme 1% testosterone cream — the first testosterone product licensed specifically for women in the UK. The UK-labelled product is expected to be available in 2026.
  • The licensed indication is hypoactive sexual desire dysfunction (HSDD) in postmenopausal women — a persistent and distressing loss of sexual desire affecting an estimated 6 to 13% of women in Europe.
  • NICE guidelines recommend testosterone for postmenopausal women with low sexual desire when HRT alone has not been effective. NHS availability of AndroFeme depends on a NICE appraisal still to be completed.
  • A 15-fold increase in testosterone prescribing for women in the UK between 2015 and 2025 reflects both growing clinical recognition and a significant prescribing gap that the MHRA approval begins to address.
  • The evidence beyond HSDD — for energy, mood, cognition, and musculoskeletal health — is promising but less well established. A 2025 pilot study found meaningful improvements in mood and cognitive symptoms.
  • Testosterone should be prescribed by a menopause specialist with appropriate monitoring. It is not a self-prescribing treatment.
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What Testosterone Does in Women

Testosterone is commonly understood as a male hormone. This framing is inaccurate and has contributed to its systematic underrecognition in women's health.

Women produce testosterone in the ovaries and adrenal glands — at lower levels than men but with comparable biological significance for specific functions. Testosterone is the primary hormone responsible for sexual motivation and desire. It also plays roles in energy and motivation, mood regulation, cognitive function, bone density, muscle mass, and vaginal and urinary tissue health.

Testosterone is not just a male hormone. It is a vital part of women's health. For too long it has been dismissed or ignored in clinical care.

Testosterone levels in women peak in the mid-20s and decline gradually through adulthood, falling sharply at perimenopause alongside oestrogen. But unlike oestrogen, which has a relatively clearly defined menopausal drop, testosterone decline is more gradual and begins earlier. Some women experience significant decline in their 30s and early 40s — well before conventional menopause. Surgical menopause — removal of the ovaries — produces an immediate, dramatic drop in testosterone production that is often inadequately addressed in post-surgical hormone management.

The symptoms of low testosterone in women include reduced libido, fatigue and low energy, poor motivation, low mood, brain fog and cognitive difficulties, reduced muscle strength and increased musculoskeletal pain, poor sleep, and vaginal dryness. Many of these symptoms overlap with oestrogen deficiency and general perimenopausal presentation — which is one reason testosterone deficiency is frequently missed or attributed entirely to other hormonal changes.

The MHRA Approval: What Is and Is Not Changing

The MHRA approved AndroFeme 1% testosterone cream in August 2025. The approval covers its use in postmenopausal women with hypoactive sexual desire dysfunction — HSDD — characterised by a persistent and distressing absence of sexual desire.

The UK has become the fourth country to license AndroFeme, following Australia, New Zealand, and South Africa.

Since 2017, AndroFeme has only been available to UK patients of private clinics under a special MHRA licence. The approval means women should be able to access AndroFeme when the UK-approved version of the product becomes available in 2026. Until then, the status quo remains.

Inclusion on the NHS has yet to be confirmed. NICE menopause guidelines say that testosterone can be considered for menopausal women with low sexual desire if HRT alone has not been effective.

The practical implication for most women in 2026: AndroFeme remains primarily accessible through private menopause clinics and private prescribing. NHS access through a GP requires a referral to a menopause specialist, and the NICE appraisal that would formally include AndroFeme on NHS formularies has not yet been completed. Women who cannot afford private prescribing may still be offered male testosterone gels — Testogel, Tostran, or Testim — at lower doses off-label on the NHS.

The significance of the approval is regulatory and clinical rather than immediately practical. It provides reassurance around quality, safety, and consistency of prescribing. It removes the uncertainty around whether a product being used is fit-for-purpose for women. And it creates the regulatory foundation for NHS formulary inclusion once the NICE appraisal is completed.

What AndroFeme Is

AndroFeme 1% testosterone cream contains 10mg/ml of testosterone — the same bioidentical form of testosterone produced by women's ovaries and men's testes. It is applied topically and dosed specifically for women, unlike previous off-label adaptations of male products.

The standard dose is 0.5ml — 5mg of testosterone — applied daily to the inner thigh or lower abdomen. This is significantly lower than doses used in male testosterone products, reflecting the different physiological requirement. The cream contains almond oil and should not be used by women with nut allergies.

Bioidentical means the testosterone molecule is structurally identical to that produced naturally by the body. This is distinct from synthetic testosterone derivatives. The bioidentical formulation produces the same effects as endogenous testosterone and is metabolised through the same pathways.

Treatment is typically trialled for three to six months to assess impact. If beneficial, ongoing prescribing may be managed in partnership between a specialist and the patient's GP. Regular monitoring — including testosterone levels, sex hormone binding globulin, and free androgen index at baseline and three and six months — is recommended.

The Evidence: What It Does and Does Not Show

The evidence for testosterone therapy in women varies considerably depending on the outcome being assessed. It is important to distinguish between what is well evidenced and what is emerging.

Sexual Function: The Strongest Evidence

The evidence for testosterone in women with HSDD is the most robust. Multiple randomised controlled trials and systematic reviews have shown that transdermal testosterone improves sexual desire, arousal, and satisfaction in postmenopausal women with HSDD.

Clinical studies have shown that testosterone therapy can improve desire and sexual satisfaction in postmenopausal women with low levels. The 2019 Global Consensus Position Statement on the use of testosterone therapy for women — endorsed by multiple international menopause societies — concluded that there is good evidence that testosterone therapy improves sexual wellbeing in postmenopausal women.

The evidence is specifically strongest for postmenopausal women with HSDD — the licensed indication. Evidence for premenopausal women and for testosterone use not associated with diagnosed HSDD is less established, though many clinicians report benefit in perimenopausal women and in women with surgical menopause.

Mood and Cognition: Promising and Growing

Beyond sexual function, the evidence for testosterone's effects on mood, energy, and cognition is increasingly compelling — but less definitively established.

Newson Research has found testosterone has beneficial effects on mood symptoms and cognition symptoms in perimenopause and postmenopausal women, and many women in clinics report an improvement in symptoms after replacement.

A 2025 pilot study published in Archives of Women's Mental Health found that transdermal testosterone therapy produced meaningful improvements in mood and cognitive symptoms in peri- and postmenopausal women over the treatment period. The study was a pilot — smaller and less conclusive than the HSDD evidence — but consistent with the clinical reports from menopause practitioners.

The mechanism is biologically coherent: testosterone receptors are distributed throughout the brain, including in regions responsible for mood regulation, motivation, and working memory. Testosterone influences dopamine pathways relevant to motivation and reward, and has neuroprotective effects in the hippocampus relevant to cognitive function.

Clinical evidence and practice suggest some women may also experience improvements in areas such as energy, mood, cognition, sleep, hair, skin, and musculoskeletal health when testosterone is used appropriately under specialist supervision.

The honest position: these benefits are real in clinical experience and increasingly supported by research, but the evidence base is not yet as robust as for sexual function. The prescribing guidance reflects this by making HSDD the primary indication — not because mood and cognitive benefits do not occur, but because the evidence threshold for formal indication is higher.

What Remains Uncertain

Long-term safety data — tracking women on testosterone therapy for more than five to ten years — remains limited. There has been a 15-fold increase in testosterone prescribing between 2015 and 2025. This rapid increase in prescribing has outpaced the availability of long-term safety data, which is the primary reason for the cautious approach in formal prescribing guidance.

The side effects of excess testosterone in women — acne, increased body hair, scalp hair loss, clitoral enlargement, voice deepening — are dose-dependent and largely avoidable with appropriate monitoring and dose adjustment. At the doses used in female-specific prescribing, these side effects are uncommon when monitoring is consistent. The concern is primarily about prescribing without adequate monitoring — which is more likely in an unregulated environment than in specialist care.

Who Can Access It and How

Postmenopausal women with HSDD: The licensed indication. These women should be offered testosterone consideration if HRT alone has not addressed their low sexual desire after at least three months of optimised HRT. NICE guidelines specifically support this pathway.

Perimenopausal women: Not the licensed indication of AndroFeme, but testosterone is increasingly recognised as relevant for perimenopausal women — particularly those with surgical menopause. Prescribing in this group remains off-label but is supported by clinical guidelines and specialist practice.

Current access routes:

  • Privately through a menopause specialist or private clinic — the most accessible current route. A 50ml tube of AndroFeme costs approximately £121 including postage at private clinics — around £1 per day at the standard dose.
  • On the NHS through a menopause specialist referral — possible but requires a referral and may involve male testosterone gels rather than AndroFeme until NHS formulary inclusion is confirmed.
  • Through a GP directly — NHS GPs can prescribe testosterone but NICE guidance recommends specialist input. Most GPs will refer to a menopause specialist rather than initiating testosterone prescribing independently.
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What to do if you think testosterone may be relevant for you:

Start with a GP appointment, raise your symptoms specifically — including loss of libido, fatigue, brain fog, and mood changes — and request a referral to a menopause specialist or NHS menopause clinic. Bring the NICE NG23 guideline recommendation on testosterone to the appointment if needed. If NHS access is delayed, private menopause clinics including Balance, Newson Health, and others offer specialist appointments with testosterone prescribing capability.

Monitoring and Safety

Testosterone therapy in women requires specific monitoring that should not be skipped.

Before starting: total testosterone, sex hormone binding globulin (SHBG), and free androgen index (FAI) should be measured to establish baseline levels and assess whether deficiency is present.

At three and six months: the same tests, to confirm levels are within the target range for women — not exceeding upper normal female range. Monitoring annually thereafter alongside HRT review.

Women should fast before testing where possible, as food can affect cortisol and insulin, which interact with testosterone levels.

Signs of excess testosterone — increased acne, increased body or facial hair, scalp hair thinning — should be reported to the prescriber and may indicate a dose reduction is needed. Adverse events should be reported to the MHRA via the Yellow Card scheme.

FAQ

What is AndroFeme and why was it approved?

AndroFeme is a 1% testosterone cream specifically formulated for women — the first licensed testosterone product for women in the UK. It was approved by the MHRA in August 2025 for postmenopausal women with hypoactive sexual desire dysfunction — a persistent and distressing loss of sexual desire affecting an estimated 6 to 13% of women in Europe. The approval provides the first female-specific testosterone treatment in the UK, replacing decades of off-label use of male testosterone products at lower doses.

Can I get testosterone on the NHS?

NHS availability of AndroFeme depends on a NICE appraisal that has not yet been completed. Until then, women may be prescribed male testosterone gels — Testogel, Tostran, or Testim — at lower doses off-label on the NHS. Access typically requires a referral to a menopause specialist. NICE guidelines support testosterone prescribing for postmenopausal women with low sexual desire when HRT alone has not been effective.

Is testosterone only for women with low libido?

The licensed indication is HSDD — low sexual desire in postmenopausal women. But testosterone affects energy, mood, cognition, bone density, and muscle health as well as sexual function. Many clinicians prescribe testosterone for the broader symptom complex of testosterone deficiency beyond HSDD alone. The evidence for these additional benefits is growing — a 2025 pilot study found improvements in mood and cognitive symptoms — but the evidence base is less established than for sexual function specifically.

What are the side effects of testosterone for women?

At appropriately dosed and monitored female prescribing levels, side effects are uncommon. Excess testosterone can produce acne, increased body or facial hair, scalp hair thinning, clitoral enlargement, and voice changes — all dose-dependent and largely avoidable with appropriate monitoring. Regular blood tests to confirm levels remain within the female reference range are the primary safeguard.

Can I take testosterone without taking HRT?

NHS and NICE guidelines recommend trying HRT first for at least three months before adding testosterone. Testosterone works best when combined with oestrogen — oestrogen receptors and testosterone receptors interact in ways that make the combined approach more effective than testosterone alone. Women who cannot take oestrogen-containing HRT may still be candidates for testosterone, but this requires specialist assessment.

Is testosterone safe long-term for women?

Long-term safety data beyond five to ten years remains limited — the 15-fold increase in prescribing over the past decade means large, long-term datasets are still accumulating. At female-appropriate doses with consistent monitoring, no significant long-term safety concerns have emerged in the available evidence. The position of the British Menopause Society and international consensus statements is that testosterone at female physiological doses is safe for postmenopausal women.

The Bottom Line

The MHRA approval of AndroFeme is a meaningful regulatory milestone — not because it introduces a new treatment, but because it provides the first female-specific, properly dosed, regulated product for a therapy that has been used off-label in the UK for years.

The evidence for testosterone in women with HSDD is well established. The evidence for broader benefits — energy, mood, cognition — is growing and increasingly supported by specialist clinical experience. The access picture is improving but remains primarily private in 2026, with NHS availability dependent on a NICE appraisal still to be completed.

For women experiencing the symptoms of testosterone deficiency — low libido, fatigue, brain fog, mood changes, reduced muscle strength — the message is that a licensed, regulated, female-specific treatment now exists in the UK. Getting to it through the NHS requires advocating for a menopause specialist referral. Getting to it privately is increasingly straightforward.

For a structured approach to the lifestyle foundations that support hormonal health through perimenopause and beyond — including sleep, stress, nutrition, and movement — the Perimenopause Reset and Menopause Reset from the Reset Series™ provide evidence-based frameworks that complement medical treatment rather than replacing it. Pair either with Reset Companion for personalised, day-to-day support as you put the protocol into practice.

Related reading: Perimenopause in Your 30s and 40s: Early Symptoms Explained · Cortisol Explained — and How to Reduce It Without Making Things Worse · Does Alcohol Cause Hair Loss?

Tags

womens health
menopause
perimenopause
hormones
HRT
testosterone

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