Testosterone Therapy in Women: A Literature Review of Clinical Indications, Dosing, Routes of Administration, and Safety.

Testosterone (T) therapy has been used to address symptoms in women such as low libido, fatigue, and mood disturbances. Despite nearly a century of global use and consistent patient demand, the Food and Drug Administration (FDA) has yet to approve a T formulation for women. This narrative review examines the physiological role of T in females, the clinical presentation of androgen insufficiency, and the evidence supporting T therapy in both pre-and post-menopausal women. Androgens are critical to female health, with T being the most abundant biologically active sex androgen in women. It is produced in the ovaries and adrenal glands and acts via androgen receptors found throughout the body. T levels in women decline gradually with age and more sharply following menopause or surgical oophorectomy, often resulting in symptoms like hypoactive sexual desire disorder (HSDD), vasomotor symptoms, and mood changes. Diagnostic challenges persist due to inconsistent laboratory assays and hormonal variability, but a symptom-based clinical approach is increasingly recognized as more reliable than relying solely on serum levels. Evidence from decades of clinical use and numerous studies supports the safety and effectiveness of T therapy, particularly via subcutaneous implants and transdermal patches. Although concerns exist around supraphysiologic doses, these are often necessary for symptom relief and are generally well-tolerated. Adverse effects are typically mild and reversible, with acne and hirsutism being the most common. Existing long-term safety data, including from transgender medicines, have not yet shown increased risks of breast cancer or cardiovascular disease at therapeutic doses. In the absence of FDA-approved formulations for women, many patients rely on compounded therapies with variable quality and oversight. This regulatory gap limits access to standardized, evidence-based care. Given the widespread and growing use of T in women, long-term randomized controlled trials (RCTs) are urgently needed to establish clear dosing guidelines, safety parameters, and approval pathways. Women deserve access to regulated, effective treatments grounded in scientific evidence.