United States health regulators are preparing to review scientific evidence on testosterone therapy for menopausal women, addressing a growing demand for off-label treatments while medical experts debate the lack of long-term safety data and clinical indications.
Testosterone has long been viewed as a male-dominated hormone, but women produce it naturally and rely on it for overall physiological health. Between ages 20 and 40, women experience about a 25 percent decline in testosterone levels, followed by another 10 to 20 percent drop by their early 50s before levels flatten out, according to reporting from the Los Angeles Times.
That steep decline can trigger persistent fatigue, mental dullness, and shifts in vitality that routine sleep or caffeine cannot fix. With perimenopause entering broader cultural conversations and longevity clinics expanding rapidly, women are increasingly asking their physicians about hormone panels and testosterone supplementation.
The Physiological Role of Testosterone in Female Health
In the female body, testosterone is primarily produced by the sex organs and plays an active role in regulating mood, sexual desire, energy, muscle strength, bone density, and metabolic stability. Typical adult testosterone levels for women hover around 40 nanograms per deciliter, though the standard range spans from 15 to 70 nanograms per deciliter, noted the Cleveland Clinic.
By comparison, normal male testosterone ranges from 193 to 824 nanograms per deciliter. Experts caution that there is no strictly defined deficiency threshold for women, and blood testing can be complicated by natural hormonal fluctuations across the menstrual cycle.
Common symptoms associated with low testosterone include diminished sex drive, irregular menstrual cycles, low energy, mood changes, brain fog, loss of muscle mass, and insomnia. However, physicians emphasize that these indicators are multifactorial.
“Part of the confusion with testosterone and estrogen is that we genderize them and call them ‘sex hormones.’ But in reality, both have important biological functions in both men and women.”
Dr. Talia Crawford, ob/gyn at Cleveland Clinic
Because fatigue and cognitive sluggishness can stem from numerous underlying causes, doctors stress that it is difficult to pin such symptoms solely on testosterone levels.
Regulatory Scrutiny and the Evidence Gap
The U.S. Food and Drug Administration has not approved any specific testosterone treatment for women. When clinicians prescribe testosterone off-label to treat hypoactive sexual desire disorder—characterized by low sexual desire—they typically rely on small doses adapted from products approved for men, such as dividing AbbVie’s AndroGel and Keenova Therapeutics’ Testim into fractionated amounts, or utilizing individual compounding pharmacies.
To address growing questions around efficacy and safety, the Food and Drug Administration will hold a public meeting to review scientific data on the hormone’s potential benefits, risks, and dosages for menopausal women.
While clinical trials have consistently shown that low-dose testosterone improves sexual desire and satisfaction among postmenopausal women, medical professionals point to a severe lack of long-term data for broader applications.
“We know testosterone has beneficial effects for women. But we just don’t have data to support supplementing testosterone in women for other symptoms, like low energy or maintenance of bone and muscle mass.”
Dr. Talia Crawford, ob/gyn at Cleveland Clinic
Other nations, including the United Kingdom, Australia, New Zealand, and South Africa, have approved specific testosterone products for women. Meanwhile, regulatory resistance in the United States has historically centered on missing long-term safety data regarding cardiovascular health and breast cancer risks.
Risks, Delivery Methods, and Safety Precautions
Prescription transdermal creams applied to the lower abdomen or buttocks are considered the safest and most common administration method in the United States, whereas injections and pellet implants carry a higher risk of causing excessive hormone absorption and adverse side effects.
Potential side effects of excess testosterone exposure include acne, increased facial or body hair growth, male-pattern baldness, blood lipid abnormalities, clitoral enlargement, and voice deepening, which can become permanent.
Furthermore, testosterone is generally not recommended for women with a history of breast cancer because the hormone can convert into estrogen in the body, potentially stimulating certain cancer cells.
As federal regulators prepare to weigh the scientific evidence, specialists emphasize that establishing a specifically approved product for women could eventually standardize dosing, labeling, and safety monitoring while improving insurance coverage access for patients navigating perimenopause and menopause.