Testosterone in Menopause: What We Know, What We Don't, and Why the FDA Is Asking Questions

Why testosterone in menopause is receiving so much attention

Women are asking increasingly direct questions about testosterone in menopause:
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• Can testosterone improve low libido?
• Does menopause cause testosterone deficiency?
• Can testosterone help with fatigue, brain fog, mood, or weight?
• What should a testosterone blood test show?
• Is testosterone therapy safe for the heart and breasts?

The timing is significant. On September 17, 2026, the FDA Office of Women’s Health and Center for Drug Evaluation and Research will hold a public workshop titled “Testosterone Use in Menopausal Women.” The hybrid workshop will examine current evidence and knowledge gaps involving sexual function, cognition, mood, musculoskeletal health, testosterone measurement, monitoring, and long-term cardiovascular and breast safety.

The FDA is not announcing approval, rejection, or a crackdown. It is asking where the evidence is strong, where it remains uncertain, how treatment should be studied and monitored, and what research is still needed.

Women make testosterone tooTestosterone is not exclusively a male hormone. Women produce testosterone through the ovaries and adrenal glands, as well as through peripheral conversion of androgen precursors in other tissues.

Testosterone can act directly through the androgen receptor. It can also be converted into other active hormones, including dihydrotestosterone and estradiol. These pathways help explain why testosterone has biologic relevance to female sexual physiology and other body systems.

Men do not own testosterone, and women do not own estrogen. Both sexes produce multiple sex steroids, although concentrations, metabolism, and physiologic effects differ.

​Watch our full Testosterone + Menopause educational video.

Book an appointment to discuss your symptoms, prior testing, and next steps with Lakeline Wellness.

Female androgen physiology diagram showing ovarian and adrenal production, peripheral conversion, and the shared biology of sex hormones. The graphic is educational and does not imply that hormone therapy is automatically indicated.
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Does menopause automatically cause testosterone deficiency?

No.

Menopause involves a major change in ovarian estrogen and progesterone production. Testosterone does not necessarily follow the same pattern or decline abruptly in every woman during the menopausal transition. Testosterone levels are influenced by age, ovarian function, adrenal androgen production, prior ovarian surgery, medications, binding proteins, and individual physiology.

Women who undergo bilateral oophorectomy may experience a more abrupt reduction in ovarian androgen production than women undergoing natural menopause. That distinction matters.

There is also no universally accepted serum testosterone concentration that independently diagnoses a female testosterone-deficiency syndrome. A low laboratory value and a clinical syndrome are not automatically the same thing.

Where testosterone therapy has the strongest evidence

The strongest evidence for systemic testosterone therapy in women concerns appropriately selected postmenopausal women with hypoactive sexual desire disorder, or HSDD.

The 2019 Global Consensus Position Statement and the 2021 International Society for the Study of Women’s Sexual Health guideline conclude that testosterone may provide a moderate improvement in sexual function for this population when transdermal therapy is used at physiologic doses.

This does not mean testosterone has been proven to improve every symptom associated with menopause.

There is a large difference between saying testosterone has an evidence-supported role in selected women with HSDD and saying testosterone is a general treatment for fatigue, brain fog, weight gain, mood changes, or aging.

What HSDD actually means

HSDD is not simply a reduction in libido compared with an earlier period of life. It refers to persistent or recurrent low sexual desire associated with clinically meaningful personal distress after appropriate evaluation.

Desire is affected by multiple factors. A careful assessment may consider:

• Relationship and interpersonal factors
• Sleep quality and chronic stress
• Depression or anxiety
• Medications, including some antidepressants
• Pain with intercourse
• Genitourinary syndrome of menopause
• Estrogen status
• Medical illness
• Thyroid and other endocrine contributors

A testosterone concentration does not diagnose HSDD.

You diagnose the patient, not the testosterone number.

Where claims may exceed the evidence

Testosterone has biologic roles in multiple tissues. That does not establish that testosterone therapy improves every symptom associated with those tissues.

Current evidence is strongest for sexual function in appropriately selected women with HSDD. Evidence for energy, mood, memory, cognition, brain fog, bone health, muscle mass, body composition, weight loss, metabolic health, general well-being, and anti-aging is variable, limited, or insufficient for routine treatment recommendations.

The distinction is important:
> Plausible physiology is not the same thing as demonstrated clinical benefit.

Mechanistic research may explain why an intervention could work. Controlled human trials help determine whether it produces a meaningful outcome in the population studied.

“Not proven” is also not identical to “proven not to work.” Where evidence is limited, the appropriate conclusion is uncertainty, not certainty in either direction.

Outcome-by-outcome evidence map using cautious tiers rather than promotional or dismissive labels. HSDD is shown as the best-supported indication; other outcomes are identified as variable, limited, or lacking sufficient long-term data.

Why one testosterone number is not enough

Testosterone testing in women is technically difficult because concentrations are relatively low and some commonly used assays are less reliable at female levels.
Interpretation may involve:
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• Total testosterone, the amount circulating in the blood
• Sex hormone-binding globulin, or SHBG, a protein that binds testosterone
• Free or bioavailable testosterone, which refers to fractions less tightly bound to proteins
• The assay method and its sensitivity
• Medication effects
• Oral estrogen use
• Thyroid physiology
• Metabolic factors, including insulin resistance
• Changes in binding proteins

Oral estrogen can increase SHBG, which may alter the amount of circulating testosterone that is available to tissues. Thyroid conditions and metabolic physiology can also affect binding proteins and interpretation.

Current guidance does not support using total testosterone alone to diagnose HSDD. A baseline measurement may provide context, while follow-up testing can help determine whether treatment is producing physiologic or supraphysiologic exposure.

The testosterone number may be more useful for monitoring exposure than for deciding, by itself, whether a woman needs treatment.

Laboratory interpretation diagram separating what testing can help assess, baseline context and treatment exposure, from what it cannot determine alone, whether a patient has HSDD or requires therapy.

Dose and formulation matter

Physiologic female testosterone exposure and supraphysiologic androgen exposure are not the same therapeutic situation.

The evidence base primarily involves non-oral, particularly transdermal, therapy designed to maintain testosterone within the physiologic premenopausal range. More testosterone is not necessarily better.

Excess exposure can produce androgenic effects such as acne, increased facial or body hair, scalp hair loss in susceptible women, voice changes, or other virilizing effects. These effects are not reasons to sensationalize treatment, but they are reasons to use an appropriate dose and monitor clinically.

Physiologic does not mean unlimited. Hormones work because dose matters.

There is currently no FDA-approved systemic testosterone formulation specifically approved for women in the United States. Clinicians may use appropriately reduced doses of approved male formulations off-label. Some clinicians and patients also encounter compounded preparations.

Compounded products are not automatically identical in quality or automatically unsafe. However, professional guidance has raised concerns about consistency, reproducibility, and the limited efficacy and safety data available for compounded testosterone. The formulation, dose, source, and monitoring plan should be discussed explicitly.

Oral testosterone has raised greater concern about lipid effects and is not the route on which the strongest contemporary evidence is based. Pellets and injectable formulations may also produce less predictable or excessive exposure and are not supported by the same evidence as carefully dosed transdermal therapy.

What we know, and do not know, about long-term safety

Short-term studies of physiologic-dose, non-oral testosterone have generally not identified serious safety signals in appropriately selected women. Acne and increased hair growth are among the more consistently reported adverse effects.
That is not the same as proving lifelong safety.

Long-term cardiovascular, breast, metabolic, ovarian, and endometrial safety remain incompletely characterized. Many studies were relatively short and excluded women with substantial baseline cardiovascular or metabolic risk.

We have useful short-term safety information, but the quality and duration of long-term data are not sufficient to make sweeping statements about lifelong cardiovascular or breast safety.

Testosterone has not been proven to cause cardiovascular disease or breast cancer. It has also not been proven completely free of those risks.

Identifying uncertainty should not frighten patients. It should make clinical decision-making more scientifically honest.

Testosterone does not exist in isolation

Consider a 55-year-old woman with decreased libido, fatigue, weight gain, reduced muscle mass, poor sleep, mood changes, and brain fog. Someone tells her, “You need testosterone.”
That conclusion is premature.

An appropriate evaluation may consider sleep quality and sleep apnea, medications, thyroid physiology, metabolic health, insulin resistance, activity level, muscle mass, iron status, depression or anxiety, pain with intercourse, genitourinary syndrome of menopause, relationship factors, chronic stress, and, when clinically appropriate, relevant hormone testing.

Not every patient needs every test. The point is diagnostic reasoning.

Adding testosterone to a complicated endocrine picture does not make the endocrine picture less complicated. The same principle applies when distinguishing menopause symptoms from thyroid-related symptoms; see Menopause or Thyroid? How Austin Women Can Interpret Overlapping Symptoms.

The two easy mistakes

Mistake one: dismissing testosterone because it has traditionally been called a “male hormone.”

That ignores female androgen physiology and the evidence supporting treatment for selected women with HSDD.

Mistake two: assuming that because testosterone has biologic roles in women, giving more testosterone must improve every tissue containing an androgen receptor.

That exceeds the available clinical evidence.

There is a large space between those two positions, and that is where actual clinical medicine lives.
What the FDA workshop may help clarifyThe September 17 FDA workshop may help define priorities for future research, including:

• Which clinical outcomes should be studied
• How HSDD and other symptoms should be defined
• How testosterone should be measured at female concentrations
• How treatment exposure and clinical response should be monitored
• Which formulations and doses should be evaluated
• How cardiovascular and breast safety should be studied over longer periods

The related Federal Register docket, FDA-2026-N-5479, accepts public comments through October 19, 2026. The workshop itself is a scientific and regulatory discussion, not a treatment recommendation.

Practical questions to discuss with your clinician

If you are considering testosterone for women during or after menopause, ask:

1. What specific clinical problem are we trying to treat?
2. Is testosterone biologically relevant to that problem?
3. What evidence supports testosterone for that specific indication?
4. Have sleep, medications, pain, mood, genitourinary symptoms, relationships, thyroid function, and metabolic factors been considered?
5. What dose and formulation are being used?
6. Is treatment staying within physiologic female exposure?
7. How will symptoms, laboratory exposure, and adverse effects be monitored?
8. Is there meaningful improvement?
9. Are the benefits sufficient to justify the known risks and remaining uncertainties?
10. What is the plan if treatment does not help?

For women in Austin, Cedar Park, and surrounding Central Texas communities, Lakeline Wellness provides individualized review of symptoms, health history, prior records, and appropriate diagnostic information through its Diagnostic & Functional Testing pathway. Patients who are unsure where to begin can review the new-patient process.

Conclusion

Testosterone matters to female physiology. The evidence also matters.
For appropriately selected postmenopausal women with HSDD, systemic transdermal testosterone may provide a moderate improvement in sexual function. That evidence does not establish testosterone as a universal treatment for every symptom attributed to menopause.

For women experiencing changes in libido, energy, body composition, mood, or other symptoms during menopause, testosterone may be one part of the clinical discussion, but it should not be considered in isolation from the rest of the endocrine and medical picture. A thoughtful evaluation can help determine which factors are actually contributing and whether hormone therapy is appropriate.


Primary References

1. U.S. Food and Drug Administration. FDA Public Meeting: Testosterone Use in Menopausal Women, September 17, 2026. FDA Office of Women’s Health and Center for Drug Evaluation and Research. Docket FDA-2026-N-5479. https://www.fda.gov/consumers/womens-health-events/fda-public-meeting-testosterone-use-menopausal-women-09172026
2. Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women’s Sexual Health clinical practice guideline for the use of systemic testosterone for hypoactive sexual desire disorder in women. Journal of Sexual Medicine. 2021;18(5):849-867. doi: 10.1016/j.jsxm.2020.10.009. PMID: 33814355.
3. Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. Journal of Clinical Endocrinology & Metabolism. 2019;104(10):4660-4666. doi: 10.1210/jc.2019-01603. PMID: 31498871.
4. Clayton AH, Goldstein I, Kim NN, et al. The International Society for the Study of Women’s Sexual Health process of care for management of hypoactive sexual desire disorder in women. Mayo Clinic Proceedings. 2018;93(4):467-487. doi: 10.1016/j.mayocp.2017.11.002. PMID: 29545008.
5. Islam RM, Bell RJ, Green S, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes & Endocrinology. 2019;7(10):754-766. doi: 10.1016/S2213-8587(19)30189-5. PMID: 31353194.

Disclaimer: This information is for educational purposes only and is not intended to diagnose or treat any medical condition. Please consult with a healthcare professional before starting any new supplement or dietary regimen. See our full disclaimers here.