The September 2026 FDA workshop on testosterone use in menopausal women provided an important opportunity to bring scientific evidence, clinical experience, and patient needs into the regulatory conversation. Dr. James Simon, Medical Director of IntimMedicine Specialists in Washington, DC, highlighted how much the science has advanced since an FDA advisory committee considered a testosterone patch for women nearly 22 years earlier. Joining medical experts, researchers, and patient advocates, he called attention to persistent treatment barriers and emphasized that women’s voices should help shape the path forward.
Putting Patients at the Center of the Conversation
Dr. Simon emphasized that symptoms affect women’s lives and relationships, and that patients should help define what meaningful treatment outcomes look like. He described the extraordinary engagement of patients, clinicians, and advocates as a reason for optimism.
His message was clear: progress depends on considering scientific rigor, clinical experience, and patient voices together.
What the Evidence Supports
Decades of research have advanced our understanding of testosterone in women. The strongest evidence supports testosterone therapy for appropriately selected postmenopausal women with hypoactive sexual desire disorder, or HSDD, which involves persistently low sexual desire that causes personal distress.
Clinical guidance emphasizes careful evaluation, appropriate dosing, and ongoing monitoring. Testosterone is not an established treatment for every symptom associated with menopause.
Advocating for patients means supporting access to evidence-based care while being clear about the benefits, limitations, and unanswered questions.
Addressing Barriers to Treatment
Dr. Simon highlighted unmet needs involving the absence of an FDA-approved testosterone product specifically for women, reliance on off-label and compounded therapies, and cost concerns.
These barriers affect the options available to patients and clinicians. Addressing them requires continued research, clinician education, and attention to the practical challenges women encounter when seeking care.
Looking Beyond a Laboratory Number
Dr. Simon explained that testosterone reference ranges vary by laboratory method and patient population. These ranges are not universal diagnostic thresholds or treatment targets.
His message was to interpret results within each woman’s clinical context, including her age, ovarian status, other hormone use, and the timing of testing. A laboratory number alone cannot capture the full picture of a patient’s symptoms and health.
Supporting Informed Treatment Decisions
During the Q&A, Dr. Simon emphasized patient autonomy and shared decision-making. He discussed evaluating individual health risks and obtaining informed consent so patients can participate meaningfully in decisions about their care.
He also distinguished individualized clinical decisions from the evidence needed to guide broader treatment recommendations and FDA approval. Other panelists expressed more conservative views about treating patients with significant health risks, underscoring the need for careful assessment and clear communication about uncertainty.
Advancing Research and Patient Care
Important questions remain about long-term safety and potential uses beyond HSDD. The FDA workshop examined these evidence gaps to help inform future research and potential drug development.
Looking beyond sexual function, Dr. Simon identified preserving muscle mass and strength and preventing age-related muscle loss as priorities for future research. These remain areas for investigation rather than established benefits of testosterone therapy.
His participation reinforced the importance of keeping patient needs visible as the science advances.
Watch the Two-Part Discussion
Hear Dr. Simon and fellow participants discuss the evidence, unmet needs, and barriers shaping testosterone therapy for women.
Watch Part 1: FDA Workshop with Dr. James Simon
Watch Part 2: FDA Q&A Panel with Dr. James Simon
Your Concerns Deserve to Be Heard
At IntimMedicine Specialists, conversations about menopause, sexual health, and hormone therapy begin with understanding your concerns and goals.
Contact IntimMedicine Specialists to schedule a consultation.
