A new conversation about menopause care is gathering momentum—and it centers on a hormone more often associated with men. On September 17, the U.S. Food and Drug Administration will convene a public workshop on testosterone use in menopausal women. The meeting is a timely sign that patients’ questions about libido, energy, mood and muscle health are finally being examined alongside the limits of the current evidence.
Testosterone is not exclusively a male hormone. Women produce it in the ovaries and adrenal glands, and levels generally decline with age. Menopause also brings major shifts in estrogen and progesterone. Yet the important question is not simply whether a blood test shows a “low” testosterone level. The FDA notes that there are unresolved challenges in measuring and interpreting testosterone levels in women, as well as uncertainty about which symptoms those numbers meaningfully explain.
That distinction matters because social-media marketing has often raced ahead of clinical science. Some menopause clinics and wellness companies promote testosterone as a broad answer to fatigue, brain fog, weight change, diminished exercise capacity and low sexual desire. But a global consensus statement endorsed by major menopause and endocrine organizations concludes that the only evidence-based indication for testosterone therapy in women is hypoactive sexual desire disorder, or HSDD, in postmenopausal women after a thorough assessment.
HSDD is not a label for every period of reduced interest in sex. It describes persistently low sexual desire that causes personal distress. Desire can be influenced by vaginal dryness or pain, sleep disruption, medications, depression, relationship pressures, stress, chronic illness and the practical overload of midlife. That is why expert guidance calls for a biopsychosocial assessment, one that considers physical, emotional and relational contributors before treatment is considered.
For appropriately selected postmenopausal patients with HSDD, the evidence is meaningful but modest. In trials of testosterone doses designed to approximate premenopausal levels, women reported improvements in sexual desire, arousal, orgasm, pleasure and sexual distress. The global consensus panel estimates an average increase of about one additional satisfying sexual event per month beyond placebo or comparison treatment. That result may be valuable for an individual patient, but it is not a promise of restored youth or a cure-all for menopause.
The larger uncertainty is safety over time. Available studies have not established the long-term effects of testosterone therapy on cardiovascular outcomes or breast-cancer risk, particularly because many trials were relatively short and excluded people at higher cardiometabolic risk. The FDA’s upcoming workshop specifically identifies these long-term safety gaps, along with unanswered questions about cognition, mood and musculoskeletal health.
In the United States, clinicians who prescribe testosterone for women frequently use products developed for men at much lower doses, making careful monitoring essential. The evidence base does not support aiming for high levels or diagnosing “testosterone deficiency” from a single laboratory result. The International Menopause Society’s recent recommendations emphasize that no blood-test threshold can by itself define a woman as testosterone-deficient. Levels are useful primarily to avoid excessive dosing and to guide safe follow-up, not to replace a clinical conversation.
Patients should also approach compounded “bioidentical” testosterone with care. “Bioidentical” sounds reassuring, but it does not automatically establish product quality, dose consistency or long-term safety. The consensus statement advises against compounded testosterone for HSDD when an approved equivalent is available, citing insufficient evidence for efficacy and safety. A clinician should discuss the formulation, dose, possible side effects (such as acne or increased hair growth) and a plan for reassessment.
The FDA meeting will not instantly create a new medication or settle every debate. What it can do is more fundamental: focus researchers, regulators and clinicians on the data needed to develop therapies designed and studied for women. For people navigating menopause now, the practical takeaway is clear. Low desire deserves to be taken seriously, but it also deserves a careful diagnosis, evidence-based options and honest discussion of what medicine knows and what it still needs to learn.
This article is for general information and is not a substitute for individualized medical care.
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