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Menopause is something nearly every woman will go through. As fertility ends, levels of estrogen and progesterone drop significantly – changes that can deeply affect physical health, emotional wellbeing and everyday life.
For many, the effects of this hormonal shift are more than frustrating – they can be life altering. Symptoms like brain fog, hot flushes, night sweats, headaches, insomnia, fatigue, joint pain, low libido, anxiety, depression and even bone loss from osteoporosis are all common.
Hormone replacement therapy (HRT) has helped many women manage these symptoms – but one key hormone is often overlooked in both treatment and conversation: testosterone.
Testosterone is typically viewed as a “male hormone,” but it plays a crucial role in women’s health too. In fact, women have higher levels of testosterone than either estrogen or progesterone for most of their adult lives. And like the other sex hormones, testosterone also declines with age – with consequences that are only now being fully explored.
The Testosterone Gap
Hormone replacement therapy (HRT) is now widely used to replace estrogen and progesterone during and after menopause. These treatments – available as tablets, patches, gels and implants – are regulated, evidence-based and increasingly accessible through the NHS.
But when it comes to testosterone, the situation is entirely different.
Currently, there are no testosterone products licensed for use by women in the UK or Europe. The only exception is in Australia, where a testosterone cream specifically designed for women is available. Europe once had its own option – a transdermal patch called Intrinsa, designed and approved by regulators based on clinical evidence to treat low libido in women with surgically induced menopause. But the manufacturer withdrew product in 2012, citing “commercial considerations” in their letter to the European Medicines Agency, the agency in charge of the evaluation and supervision of pharmaceutical products in Europe.
Since then, women across Europe have been left without an approved option.
In the absence of licensed treatments, some clinicians – mainly in private practice – are prescribing testosterone “off label,” often using products developed for men. These are typically gels or creams with dosages several times higher than most women need. While doctors may advise on how to adjust the dose, this kind of improvisation comes with risks: inaccurate dosing, inconsistent absorption and a lack of long-term safety data.
Some women report significant improvements – not just in libido, but also in brain fog, mood, joint pain and energy levels. However, the only proven clinical benefit of testosterone in women is in improving sexual desire for those with hypoactive sexual desire disorder (HSDD) following surgical menopause.
Even so, interest is growing – fueled by patient demand, celebrity use, social media buzz and a growing sense that testosterone may be a missing piece in midlife women’s care.
While there is increasing consensus that testosterone can play a role in supporting women’s health, the current situation presents two serious problems:
Safety and regulation: without licensed products, standardized dosing guidelines, or long-term safety data, off-label use puts both patients and clinicians in uncertain territory.
Access and inequality: testosterone therapy is rarely available through the NHS and is often only accessible through private clinics, creating a two-tier system. Those who can pay hundreds of pounds for consultations and prescriptions can access care, while others are left behind.
Innovation
There are signs of change. For example, I founded Medherant, a University of Warwick spin-out company that is currently developing a testosterone patch designed specifically for women. It’s in clinical trials and, if approved, could become the first licensed testosterone product for women in the UK in over a decade. It’s a much-needed step – and one that could pave the way for further innovation and broader access.
But the urgency remains. Millions of women are currently going without effective, evidence-based care. In the meantime, off-label prescribing should used with care and use based on the best available science – not hype or anecdote – and delivered through transparent, regulated healthcare channels.
Women deserve more than workarounds. They deserve treatments that are developed for their bodies, rigorously tested, approved by regulators and accessible to all – not just the few who can afford private care.
When half the population is affected, this isn’t a niche issue. It’s a priority.
David Haddleton, Professor in Polymer Chemistry, University of Warwick. He works for and owns shares in Medherant Ltd.
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Ani Pharmaceuticals (formerly Biosante Pharmaceuticals) has yet to announce it, but they have requested to delay submitting results from their 3,656 participant long-term LIBIGEL safety trial, where part way through the study they learned that restoring testosterone to pre-menopausal levels, in post-menopausal women at a higher risk of experiencing cardiovascular events, reduced the risk of cardiovascular events by 70% and the risk of breast cancer events events by an undisclosed amount.
Ani Pharmaceuticals filed an New Drug Application with the FDA where an undisclosed partner paid the NDA application fee. There is a good possibility that the NDA is for LIBIGEL. IF so, than the US should soon see their first FDA approved female testosterone drug.