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CAPE TOWN, SOUTH AFRICA – MAY 31: Suz Redfern and her husband Marty wait at the Cape Town clinic. (Photo by Per-Anders Pettersson\/Getty Images)<\/p>\n
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Testosterone is often thought of as a male hormone.But women produce it throughout life, and it acts on androgen receptors across the body. Still, the United States has no FDA-approved testosterone product<\/a> for women.<\/p>\n That disconnect reflects a larger challenge in women\u2019s health: what women experience clinically and what medicine has rigorously studied are not always aligned. The distance between the two reflects decades of research funding gaps, regulatory decisions, clinical education, and healthcare systems that have not consistently considered hormonal health as part of the broader picture of women\u2019s health across an entire lifetime. <\/p>\n Dr. Komal Bajaj <\/a>is a board-certified OB\/GYN and clinical geneticist who previously served as an enterprise chief quality officer and is now Chief Medical Officer at Biote<\/a>. I spoke with her about what the evidence supports today, the legacy of the Women\u2019s Health Initiative and what it will take to responsibly expand women\u2019s options.<\/p>\n Q: You have built your career around quality, patient safety and diagnostic excellence. What connected that work to women\u2019s hormonal health?<\/strong><\/p>\n Across my career, the core question has been remarkably consistent: how do we design systems that close the gap between evidence and practice? I have worked on the outcomes health systems measure and are held accountable for – hospital-acquired infections, falls, readmissions and wound complications. Improving those outcomes saves lives.<\/p>\n More recently, I\u2019ve become focused on how hormone physiology impacts those outcomes. Hormones are known to interact with many of the systems involved in health and recovery, including muscle, bone, sleep, inflammation, metabolism, and immune function. Understanding the nuances of that impact is where the work needs to go next.<\/p>\n Q: Women produce testosterone, yet there is no FDA-approved product for them in the United States. How do you make sense of that gap?<\/strong><\/p>\n I\u2019ve spent years studying where healthcare systems struggle to get to the right diagnosis at the right time and working to fix it. This is one of the more striking gaps I\u2019ve encountered. <\/p>\n It\u2019s important to place the lack of FDA-approved testosterone therapy for women in the broader history of hormone therapy. The 2002 Women\u2019s Health Initiative<\/a> fundamentally changed the trajectory of menopausal hormone treatment. Its initial findings were widely interpreted as evidence that hormone therapy broadly increased women\u2019s risks of adverse events and as a result, healthcare workers abruptly stopped prescribing it. Over the following two decades, longer-term research and nuanced analysis gave us a more clearer understanding. Hormone therapy is not a single intervention. Benefits and risks vary according to factors including the hormone and formulation used, route of administration, a woman\u2019s age, timing relative to menopause, and her individual risk profile. For appropriately selected women, contemporary menopause guidance recognizes a favorable benefit-risk profile<\/a>.<\/p>\n Testosterone deserves that same careful attention, since we already know it plays a real, measurable role in women\u2019s health. Studies today supports testosterone therapy for hypoactive sexual desire disorder in appropriately selected postmenopausal women<\/a> and there is emerging data around bone density<\/a> improvement and decrease in cardiovascular risk<\/a> in women. <\/p>\n Limited research funding, inconsistent clinician education, and no standardized clinical pathway have predictably led to fragmented care and no approved therapeutics. It\u2019s crucial to identify what research questions remain unanswered and invest in answering them.<\/p>\n Q: You\u2019ve described women\u2019s hormonal symptoms as being normalized, fragmented across specialties, or sometimes dismissed altogether. What does that actually cost a woman when her symptoms have been explained away for years?<\/strong><\/p>\n The cost can be significant. When symptoms are attributed solely to aging without an adequate evaluation, the diagnostic process can stop prematurely. A woman may move between clinicians and specialties, with each addressing one component of her experience without anyone necessarily seeing the whole picture. That matters clinically and the consequences extend beyond the exam room. Persistent symptoms can affect well-being, relationships, the ability to work, caregiving responsibilities, and quality of life.<\/p>\n