Are elevated levels of testosterone (T) recommended for females?

From the Guidelines

Elevated levels of testosterone are not recommended for females unless medically indicated for specific conditions, such as diagnosed testosterone deficiency causing symptoms like decreased libido, fatigue, and reduced bone density. Testosterone therapy may be prescribed for women with these conditions, typically in postmenopausal women or those who have undergone surgical menopause. When prescribed, testosterone is usually given at much lower doses than for men, often as a topical gel at 1/10th the male dose, or as a cream at 0.5-2 mg daily 1.

The potential benefits of testosterone therapy in women must be weighed against the potential risks, including virilization, menstrual irregularities, and metabolic changes. The body naturally maintains hormone balance, and artificially increasing testosterone without medical necessity disrupts this balance and can lead to health complications.

Key considerations for testosterone therapy in women include:

• Monitoring treatment with blood tests every 3-6 months to maintain levels within the normal female range (15-70 ng/dL) 1
• Being aware of potential side effects, such as acne, facial hair growth, deepening voice, and potential cardiovascular risks
• Avoiding testosterone supplementation in women without a medical need, as it can cause significant adverse effects

It is essential to note that the evidence for testosterone therapy in women is limited, and more research is needed to fully understand its effects. However, based on the current evidence, testosterone therapy should only be used in women with diagnosed testosterone deficiency and under the guidance of a healthcare professional 1.

From the FDA Drug Label

5.7 Use in Women

Elevated levels of testosterone (T) are not recommended for females. The FDA drug label warns about the potential risks of testosterone use in women, but it does not provide information on recommended levels.

• Key points:
  • Testosterone is not indicated for use in females except for specific conditions, such as hypoactive sexual desire disorder (not mentioned in this label).
  • The label does not provide guidance on recommended testosterone levels for females.
  • The use of testosterone in women may be associated with adverse effects, such as virilization and other androgenic effects. 2

From the Research

Testosterone Therapy in Females

• The use of testosterone therapy in females is a topic of ongoing debate and research, with some studies suggesting its potential benefits for certain conditions, such as hypoactive sexual desire disorder (HSDD) 3, 4.
• However, other studies have raised concerns about the safety and efficacy of testosterone therapy in females, particularly in the long term 5, 6.
• The International Society for the Study of Women's Sexual Health has developed a clinical practice guideline for the use of systemic testosterone in women with HSDD, which recommends a biopsychosocial assessment and treatment approach, as well as careful monitoring of patients for signs of androgen excess and total testosterone levels 3, 4.
• The North American Menopause Society has also issued a position statement on the role of testosterone therapy in postmenopausal women, which suggests that it may be beneficial for certain women with decreased sexual desire, but notes that the evidence is limited and that more research is needed to fully understand its effects 7.

Safety and Efficacy Concerns

• The safety and efficacy of testosterone therapy in females are not fully established, particularly in the long term 5, 6.
• Potential risks associated with testosterone therapy in females include masculinization, cardiovascular effects, and cancer risks, although the evidence is limited and more research is needed to fully understand these risks 6.
• The use of compounded products is not recommended due to the lack of efficacy and safety data 3, 4.
• Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women, but patients should be carefully monitored for signs of androgen excess and total testosterone levels should be maintained in the physiologic premenopausal range 3, 4.

Recommendations for Use

• Testosterone therapy may be considered for women with HSDD who have not responded to other treatments and who have a physiologic cause for their low testosterone levels, such as bilateral oophorectomy 3, 4.
• Patients should be carefully evaluated for signs of androgen excess and total testosterone levels should be monitored regularly to maintain concentrations in the physiologic premenopausal range 3, 4.
• Clinicians should provide informed consent and engage in shared decision-making with patients, discussing the potential benefits and risks of testosterone therapy, as well as the limitations of the evidence 3, 4.