Testosterone Therapy for Women: A Midi Health Perspective

The role of testosterone therapy for women has become the focus of increasing debate, discussion, and research in both medical and cultural circles. At Midi, we welcome these conversations as—like most topics having to do with women’s health—they have been long overdue. Women's health has been historically underrepresented in clinical research, and thoughtful debate reviewing what we do and do not know advances care. As with any other treatment, discussions about testosterone should accurately reflect both what the evidence clearly supports and where important questions remain unanswered.

Our approach is built on three principles:

• Follow the best available evidence.
• Be transparent about uncertainty.
• Prioritize patient safety through careful prescribing and monitoring.

Where the Evidence is Strong

Today, the strongest evidence for testosterone therapy in women is in the treatment of hypoactive sexual desire disorder (HSDD), more commonly referred to as “low libido.”

Multiple randomized controlled trials and global consensus statements have demonstrated improvements in sexual desire as well as some evidence on improved arousal, orgasm, sexual satisfaction, and sexual distress in appropriately selected patients. Testosterone’s support of female sexual health remains the indication with the highest level of evidence in women, and it is the foundation of conversations we have with patients.

Where the Evidence is Still Evolving

Women frequently ask whether testosterone may also improve symptoms such as fatigue, cognitive changes, loss of muscle mass, changes in body composition, bone health, or overall well-being.

At present, evidence supporting testosterone for these outcomes is far less robust than it is for HSDD. While some observational studies and smaller clinical trials suggest potential benefits, randomized trials have not consistently demonstrated meaningful improvements. As a result, major professional societies appropriately conclude that more research is needed. We agree.

However, the absence of definitive evidence is not the same as evidence that a therapy has no role. In women's health, many clinically important questions remain insufficiently studied. This is not because research has shown definitively that therapies are ineffective, but because large scale studies have not yet been completed. 

Most testosterone trials were designed to test sexual function; bone, mood, and body composition were measured along the way rather than being what the studies were designed to detect. In a systematic review and meta-analysis of pooled RCTs, the available studies did not provide sufficient evidence to determine whether testosterone improves body composition, musculoskeletal health, or cognitive outcomes. The authors noted that relatively few women had been studied for these outcomes and that the effects of testosterone on these areas warrant further investigation, highlighting the limitations of the evidence rather than establishing that testosterone has no benefit.

Observational studies with testosterone are difficult to interpret because patients are often taking other hormones, typically estrogen and/or progesterone, making it difficult to tease out which hormone is impacting results. Given estrogen's well documented impact on bone and musculoskeletal health for women, it is particularly hard to tease out testosterone’s impact alone on bone and muscle mass when women are also on estrogen. In men, it is well documented that testosterone therapy can increase lean mass and support bone health. Endogenous testosterone is positively associated with lower bone fracture risk in women, including in a Women's Health Initiative study of postmenopausal women, but no study has definitively isolated testosterone therapy in women as supporting better bone health.

The studies that exist on cognition vary considerably in what they measure, how testosterone is given, and what other hormones women are taking, making it difficult to draw firm conclusions. Still, some findings are encouraging. In one small randomized trial, for example, testosterone therapy improved verbal learning and memory in postmenopausal women. This trial was exploratory and was not scaled to be definitive, but suggests more research on testosterone and cognition is warranted. Anecdotally, women often report that testosterone supports their energy and mood, while the seminal studies have not shown testosterone outperforming placebo for those outcomes.

Essentially, there are signals that testosterone may be helpful outside of HSDD but not enough scaled evidence to make overarching recommendations.

Leading women’s health professionals and societies agree that testosterone therapy at physiologic dosing is safe for most women, though more long-term safety data is needed (the landmark multicenter Traverse study in men is reassuring but studies evaluating long-term safety in women remain limited). The uncertainty around therapeutic impact and whether it is appropriate for a patient to try under the care of a clinician requires thoughtful clinical judgment, which we provide on an individualized basis.

Fortunately, the evidence base is growing: First, a trial is running. In 2024 the UK National Institute for Health and Care Research funded the ESTEEM trial, which aims to find out if adding testosterone to standard hormone replacement therapy can reduce menopausal symptoms beyond its effect on sexual function (libido). It will look at the impact of testosterone on cognition, exercise, motivation, energy, mood and focus in menopausal women. That is a publicly funded randomized control trial addressing quality-of-life outcomes directly and we look forward to seeing the results. Second, on September 17, the FDA is holding a public meeting specifically to discuss testosterone use in menopausal women—and the discussion is broader than HSDD. While this meeting won’t change anything overnight, it’s an important step toward supporting the research we need to learn more about the role of testosterone therapy in sexual function, cognition, mood, and musculoskeletal health, among other important impacts, and it’s promising to see this subject on the docket. 

How We Apply Evidence in Clinical Practice

Testosterone isn’t an established cure-all for fatigue, brain fog, muscle loss, fractures and osteoporosis, and/or lack of energy. Nor is it an anti-aging strategy. But it does help some women with HSDD, unambiguously, and some women report broader benefits, too.

Before considering testosterone, we evaluate other common contributors to persistent symptoms, including estrogen depletion, thyroid disease, iron deficiency, sleep disorders, mood disorders, medication side effects and other medical conditions.

For women whose symptoms remain bothersome despite optimization of established therapies like menopausal hormone therapy (estrogen +/- progesterone) when appropriate, it can also be reasonable to consider a therapeutic trial of testosterone after a thorough discussion of what is known, what remains uncertain, and what alternative approaches exist. Some women choose other options after that discussion. Others elect to proceed with a trial of testosterone, with follow up to see if symptoms improve. We ensure that the patient is informed and work with them in a shared decision making format.

Evidence-informed medicine integrates the best available research with clinical expertise and each patient's goals, values, and preferences. It means taking what we know from the evidence and applying it to the individual patient, understanding their issues, medical history, and health goals. This is the very essence of being a clinician—having the ability to exercise expert judgement based on the evidence and applying to the patient’s totality of circumstances.

Because physiologic-dose testosterone is well tolerated by most women, documentation of benefits exists, and patients report meaningful symptom relief, we support women trying testosterone when it is clinically appropriate and the patient understands what is known and what remains uncertain.

Safety is Central to Our Protocol

The testosterone formulation used matters as it can impact both safety and efficacy. There is currently no FDA-approved testosterone product specifically formulated for women in the United States (we would love it if there were). Professional societies including the International Society for the Study of Women's Sexual Health (ISSWSH) and The Menopause Society (TMS) recommend using FDA-approved male testosterone products off-label, at roughly one-tenth the male dose, rather than compounded formulations. In practice, this is difficult to execute safely or compliantly; dispensing such a small fraction of a male-dosed product requires a pharmacist to break open packaging not designed for partial use, which many pharmacies are unwilling or unable to do, and splitting small doses into tenths is challenging and can result in women receiving the incorrect dose. Given these constraints, we believe a carefully vetted, third party tested compounded formulation that is appropriately dosed for women is the more reliable option for our patients.

When prescribing testosterone, we:

• Evaluate and treat other common contributors to persistent symptoms first 
• Explore testosterone as a treatment solution for symptomatic patients when clinically appropriate
• Discuss the nuances of what we do and do not know directly with our patients
• Use only non-oral routes (typically transdermal cream) — clinically safer as it avoids liver and metabolic issues seen with oral formulations
• Prescribe doses intended to maintain testosterone at or around the normal female physiologic range
• Obtain baseline and follow up laboratory testing to support safe use
• Regularly assess symptom response and potential androgenic side effects
• Adjust or discontinue therapy when benefits do not outweigh risks, or when patients experience no positive impact

We recommend, prescribe, and monitor for testosterone levels within the physiologic range naturally seen in women.

Clinicians are incentivized to help the woman in front of them feel and do better; they are not compensated based on what they prescribe or recommend.

Our Philosophy

Medicine is rarely practiced in absolutes. When studies report that many women respond to a treatment, it does not mean every woman will. And, limited evidence is not the same as no evidence. Some treatments are supported by decades of research; for others, the science is still emerging, and clinicians must weigh what is known with safety and each patient's values and concerns.

Medicine today is evolving faster than ever before. Knowledge in healthcare advances on a daily basis. At Midi, we stay on top of the latest research and recommendations and update our protocols accordingly so that women benefit from up-to-date, informed care.

Our responsibility is neither to overstate what the data show nor to dismiss women whose symptoms persist simply because a randomized trial has not yet answered the question definitively. We use the data we do have—including basic science research, observational evidence, and other clinical trials—as the science evolves. We build a clinical plan from the information we have, the evidence and options available, and then practice transparently—monitoring carefully, partnering with our patients, and holding their safety above all else. That is what evidence-informed, patient-centered care looks like.